MDS G44 SFDA Recognized Standards (Supporting Medical .
MDS – G44SFDA Recognized Standards(Supporting Medical Device Premarket Submissions)Version Number: 2.0Version Date: 16/09/2020This guidance document has been published after beingdistributed for public comments dated on 3/7/2020 for 30 days.
Table of ContentIntroduction . 3Purpose. 3Scope . 3Background . 3How to Access Recognized Standards . 3List of Recognized Standards by Category . 4Annex (1): modification table . 33Annex (2): Definitions & Abbreviations . 34
IntroductionPurposeThe purpose of this guidance is to list the SFDA recognized standards, which will help in premarketsubmission and satisfy the regulatory needs.Scope This guidance applies to following parties and products:-Medical devices and their manufacturers.Research and lab centers.BackgroundSFDA/MDS has issued this guidance document in reference to the Article Four of the "Medical DevicesInterim Regulation" issued by Saudi Food and Drug Authority Board of Directors decree No. (1-81429) dated 29/12/1429 H and amended by Saudi Food and Drug Authority Board of Directors decreeNo. (4-16-1439) dated 27/12/2017 stating "medical devices may be placed on the market and/or putinto service only if they comply with the applicable provisions of the Interim Regulation, as signifiedby the SFDA issuing the manufacturer with a written marketing authorization. The SFDA may exemptany medical device from market authorization, and shall announce the exempt medical devices on itswebsite taking into consideration the public interest. In term of standard, SFDA is the responsible bodyto regulate and control food and drug through development of mandatory and non-mandatory standardsthat leads to raising the public’s awareness as stipulated in Article Three of SFDA regulation that hasbeen approved by the royal decree No (m/6) dated 25/1/1428HHow to Access Recognized StandardsSFDA publish and update regularly a list of recognized standards. These standards and other preparedor adopted Saudi standards can be accessed and purchased through the SFDA standards store(https://mwasfah.sfda.gov.sa/). In addition, international standards may be purchased through(https://www.iec.ch) or (https://www.iso.org)
List of Recognized Standards by Category#Categories & StandardsTransfusion , infusion and injection , and blood processing equipment for medical andpharmaceutical use Standards1ISO 1135-4:2015Transfusion equipment for medical use - Part 4: Transfusion sets for single use2ISO 3826-2:2008Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbolsfor use on labels and instruction leaflets3ISO 3826-3:2016Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systemswith integrated features4ISO 3826-4:2015Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bagsystems with integrated features5ISO 15747:2018Plastic containers for intravenous injectionsAnesthetic and respiratory equipment Standards6ISO 5362:2006Anaesthetic reservoir bags7ISO 4135:2001Anaesthetic and respiratory equipment - Vocabulary8ISO 7396-2:2007Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems9ISO 80601-2-13:2011/AMD 1:2015Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essentialperformance of an anaesthetic workstation — Amendment 110ISO 9170-2:2008
Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gasscavenging systems11ISO 9360-1:2000Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifyingrespired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml12ISO 9360-2:2001Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifyingrespired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidalvolumes of 250 ml13ISO 10079-1:2015/AMD 1:2018Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1:Changes to requirements for operating at extremes of temperature14ISO 10079-2:2014Medical suction equipment - Part 2: Manually powered suction equipment15ISO 10079-3:2014Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source16ISO 10524-1:2018Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulatorswith flow-metering devices17ISO 10524-2:2018Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators18ISO 10524-3:2019Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylindervalves19ISO 10524-4:2008Pressure regulators for use with medical gases - Part 4: Low-pressure regulators20ISO 10651-4:2002Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators21ISO 80601-2-79:2018Medical electrical equipment -- part 2-79: particular requirements for basic safety and essentialperformance of ventilatory support equipment for ventilatory impairment
22ISO 80601-2-80:2018Medical electrical equipment -- part 2-80: particular requirements for basic safety and essentialperformance of ventilatory support equipment for ventilatory insufficiency23ISO 11197:2019Medical supply units24ISO 15001:2010Anaesthetic and respiratory equipment - Compatibility with oxygen25ISO 18778:2005Respiratory equipment - Infant monitors - Particular requirements26ISO 19054:2005 /AMD 1:2016Rail systems for supporting medical equipment — Amendment 127ISO 23328-1:2003Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtrationperformance28ISO 23328-2:2002Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects29ISO 26782:2009Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forcedexpired volumes in humans30ISO 81060-1:2007Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automatedmeasurement type31ISO 80601-2-55:2020Medical electrical equipment – Part 2-55: Particular requirements for thebasic safety and essential performance of respiratory gas monitors32ISO 5359:2014/Amd 1:2017Anaesthetic and respiratory equipment – Low-pressure hose assemblies for use with medical gases33ISO 27427:2013Anaesthetic and respiratory equipment -- Nebulizing systems and components34ISO 2015: 12-2-80601Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essentialperformance of critical care ventilators
35ISO 18250-1:2020Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1:General requirements and common test methods36IEC 60601-1-6:2015Medical electrical equipment - Part 1-6: General requirements for basic safety and essentialperformance - Collateral standard: Usability37IEC 60601-1-8:2015Medical electrical equipment - Part 1-8: General requirements for basic safety and essentialperformance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems38IEC 60601-1-9:2015Medical electrical equipment - Part 1-9: General requirements for basic safety and essentialperformance - Collateral Standard: Requirements for environmentally conscious design39IEC-60601-1-10:2017Medical electrical equipment — Part 1-10: General requirements for basic safety and essentialperformance — Collateral standard: Requirements for the development of physiologic closed-loopcontrollers40IEC 60601-1-11:2015Medical electrical equipment - Part 1-11: General requirements for basic safety and essentialperformance - Collateral Standard: Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment41IEC 60601-1-12:2015Medical electrical equipment - Part 1-12: General requirements for basic safety and essentialperformance - Collateral Standard: Requirements for medical electrical equipment and medicalelectrical systems intended for use in the emergency medical services environment42ISO 80601-2-12:2015Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essentialperformance of critical care ventilators43ISO 80601-2-70:2017Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essentialperformance of sleep apnoea breathing therapy equipment44ISO 80601-2-72:2017Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essentialperformance of home healthcare environment ventilators for ventilator-dependent patients
45ISO 80601-2-74:2018Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essentialperformance of respiratory humidifying equipment46ISO 10651-3:1997Lung ventilators for medical use — Part 3: Particular requirements for emergency and transportventilators47ISO 10651-4:2015Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators48ISO 10651-5:2015Lung ventilators for medical use — Particular requirements for basic safety and essentialperformance — Part 5: Gas-powered emergency resuscitators49ISO 17510:2017Medical devices — Sleep apnoea breathing therapy — Masks and application accessories50ISO 18082:2015Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screwthreaded (NIST)low-pressure connectors for medical gases51ISO 5356-1:2015Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets52ISO 5356-2:2015Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weightbearing connectors53ISO 5361:2018Anaesthetic and respiratory equipment — Tracheal tubes and connectors54ISO 5366:2018Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors55ISO 5367:2015Anaesthetic and respiratory equipment — Breathing sets and connectorsImplants for surgery Standards56ISO 5840-2:2015
Cardiovascular implants - Cardiac valve prostheses57ISO 14602:2010Non-active surgical implants - Implants for osteosynthesis - Particular requirements58ISO 14607:2018Non-active surgical implants - Mammary implants - Particular requirements59ISO 14630:2012Non-active surgical implants - General requirements60ISO 16061:2015Instrumentation for use in association with non-active surgical implants - General requirements61ISO 25539-1:2017Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses62ISO 25539-2:2012Cardiovascular implants - Endovascular devices - Part 2: Vascular stents63ISO 5840-1:2015Cardiovascular implants - Cardiovascular implants - Cardiac valve prostheses - Part 1: Generalrequirements64ISO 14708-6:2019Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for activeimplantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)65ISO 14708-7:2019Implants for surgery - Active implantable medical devices - Part 7: Particular requirements forcochlear implant systems66ISO 7198:2016Cardiovascular implants and extracorporeal systems – Vascular prostheses - Tubular vascular graftsand vascular patches67ISO 14708-3:2017Active implantable medical devices -- Part 3: Implantable neurostimulators68ISO 14242-2:2016Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement69ISO 9583:1993Implants for surgery – Non-destructive testing – Liquid penetrant inspection of metallic surgicalimplants70ISO 7206-4:2010/AMD 1:2016
Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of enduranceproperties and performance of stemmed femoral components — Amendment 171ISO 13782:2019Implants for surgery – Metallic materials – Unalloyed tantalum for surgical implant applications72ISO 6474-1:2019Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina73ISO 6474-2:2019Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high purityalumina matrix with zirconia reinforcement74ISO 5834-2:2019Implants for surgery – Ultra-high molecular weight polyethylene – Part 2: Moulded forms75ISO 5832-1:2016Implants for Surgery – Metallic materials – Part 1: Wrought stainless steel76ISO 5832-2:2018Implants for surgery – Metallic materials – Part 2: Unalloyed titanium77ISO 5832-3:2016Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy78ISO 5832-4:2014Implants for surgery – Metallic materials – Part 4: Cobalt-chromiummolybdenum casting alloy79ISO 5832-5:2005Implants for surgery – Metallic materials – Part 5: Wrought cobaltchromium-tungsten-nickel alloy80ISO 5832-6:1997Implants for surgery – Metallic materials – Part 6: Wrought cobalt-nickel-chromium-molybdenumalloy81ISO 5832-9:2019Implants for surgery – Metallic materials – Part 9: Wrought high nitrogen stainless steel82ISO 23500-2:2019Water treatment equipment for haemodialysis applications and related therapies83ISO 7199:2016/AMD 1:2020Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment1: Connectors84ISO 14117:2019Active implantable medical devices - Electromagnetic compatibility - EMC test protocols forimplantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronizationdevices85ISO 14708-5:2020
Implants for surgery – Active implantable medical devices – Part 5:Circulatory support devices86ISO 23500-4:2019Preparation and quality management of fluids for haemodialysis and related therapies -- part 4:concentrates for haemodialysis and related therapiesProsthetics and orthotics Standards87ISO 10328:2016Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods88ISO 22523:2006External limb prostheses and external orthoses - Requirements and test methods89ISO 22675:2016Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methodsSurgical instruments Standards90ISO 7197:2006, including Cor 1:2007Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components91ISO 9713:2002Neurosurgical implants - Self-closing intracranial aneurysm clips92ISO 7740:1985Instruments for surgery, scalpels with detachable blades, fitting dimensions93IEC 60601-2-2:2017Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essentialperformance of high frequency surgical equipment and high frequency surgical accessories94IEC 60601-2-18:2015Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essentialperformance of endoscopic equipment (IEC 60601-2-18:2009)95EN ISO 7153-1:2000Surgical instruments – Metallic materials – Part 1: Stainless steel96ISO 7153-1:2016Surgical instruments – Materials – Part 1: Metals
Optics and photonics Standards97ISO 11810:2015Lasers and laser-related equipment -- test method and classification for the laser resistance of surgicaldrapes and/or patient protective covers -- primary ignition, penetration, flame spread and secondaryignition98ISO 11979-8:2017Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements99ISO 11990:2018Lasers and laser-related equipment -- determination of laser resistance of tracheal tube shaft andtracheal tube cuffs100BS EN ISO 14889:2013 A1:2017Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses101ISO 15798:2010Ophthalmic implants - Ophthalmic viscosurgical devices102IEC 80601-2-58:2014Medical electrical equipment -- part 2-58: particular requirements for basic safety and essentialperformance of lens removal devices and vitrectomy devices for ophthalmic surgery103ISO 18369-1:2017Ophthalmic optics – Contact lenses – Part 1: Vocabulary, classification system and recommendationsfor labelling specifications104ISO 18369-3:2017Ophthalmic optics – Contact lenses – Part 2: Measurement methods105ISO 18369-4:2017Ophthalmic optics – Contact lenses – Part 4: Physicochemical propertiesof contact lens materials106ISO 11979-1:2018Ophthalmic implants – Intraocular lenses – Part 1: Vocabulary107ISO 11979-2:2014Ophthalmic implants -- Intraocular lenses -- Part 2: Optical propertiesand test methods108ISO 11979-3:2012Ophthalmic implants – Intraocular lenses – Part 3: Mechanical properties and test methods109ISO 11979-5:2006Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility110ISO 11979-6:2014Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and
transport stability testing111ISO 11979-7:2018Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations of intraocular lenses for thecorrection of aphakiaAssistive Products112ISO 16201:2006Technical aids for disabled persons - Environmental control systems for daily living113ISO 11334-4:1999Walking aids manipulated by one arm — Requirements and test methods — Part 4: Walking stickswith three or more legs114ISO 19894:2019Walking trolleys — Requirements and test methods115ISO 7176-1:2014Wheelchairs — Part 1: Determination of static stability116ISO 7176-5:2008Wheelchairs — Part 5: Determination of dimensions, mass and manoeuvring space117ISO 7176-8:2014Wheelchairs -- part 8: requirements and test methods for static, impact and fatigue strengths118ISO 7176-11:2012Wheelchairs — Part 11: Test dummies119ISO 7176-13:1989Wheelchairs — Part 13: Determination of coefficient of friction of test surfaces120ISO 7176-15:1996Wheelchairs — Part 15: Requirements for information disclosure, documentation and labelling121ISO 7176-16:2012Wheelchairs -- part 16: resistance to ignition of postural support devices122ISO 7176-19:2008/AMD 1:2015Wheelchairs — Part 19: Wheeled mobility devices for use as seats in motor vehicles- Amendment 1:Annex G123ISO 7176-21:2009Wheelchairs -- part 21: requirements and test methods for electromagnetic compatibility ofelectrically powered wheelchairs and scooters, and battery chargers124ISO 7176-25:2013Wheelchairs -- part 25: batteries and chargers for powered wheelchairs
Biological evaluation of medical devices Standards125ISO 10993-7:2008/AMD 1:2019Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment1: Applicability of allowable limits for neonates and infants126ISO 10993-9:2009Biological evaluation of medical devices - Part 9: Framework for identification and quantification ofpotential degradation products127ISO 10993-10:2018Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization128ISO 10993-12:2012Biological evaluation of medical devices - Part 12: Sample preparation and reference materials129ISO 10993-13:2010Biological evaluation of medical devices - Part 13: Identification and quantification of degradationproducts from polymeric medical devices130ISO 10993-14:2001Biological evaluation of medical devices - Part 14: Identification and quantification of degradationproducts from ceramics131ISO 10993-15:2019Biological evaluation of medical devices — Part 15: Identification and quantification of degradationproducts from metals and alloys132ISO 10993-16:2017Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradationproducts and leachables133ISO 10993-17:2002Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachablesubstances134ISO 10993-18:2020Biological evaluation of medical devices — Part 18: Chemical characterization of medical devicematerials within a risk management process135BS EN ISO 10993-18:2020
Biological evaluation of medical devices. Chemical characterization of materialsSterilization of health care products Standards136ISO 11135:2014/AMD 1:2018Sterilization of health-care products — Ethylene oxide — Requirements for the development,validation and routine control of a sterilization process for medical devices — Amendment 1: Revisionof Annex E, Single batch release137ISO 11140-1:2014Sterilization of health care products - Chemical indicators - Part 1: General requirements138ISO 11140-3:2007, including Cor 1:2007Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for usein the Bowie and Dick-type steam penetration test139ISO 11607-1:2019Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterilebarrier systems and packaging systems140ISO 11607-2:2019Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming,sealing and assembly processes141ISO 11737-1:2018Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population ofmicroorganisms on products142ISO 11737-2:2019Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in thedefinition, validation and maintenance of a sterilization process143ISO 13408-1:2008, including Amd 1:2013Aseptic processing of health care products - Part 1: General requirements144ISO 13408-2:2018Aseptic processing of health care products - Part 2: Filtration145ISO 13408-3:2006Aseptic processing of health care products - Part 3: Lyophilization146ISO 13408-4:2005
Aseptic processing of health care products - Part 4: Clean-in-place technologies147ISO 13408-5:2006Aseptic processing of health care products - Part 5: Sterilization in place148ISO 13408-6:2005/AMD 1:2013Aseptic processing of health care products — Part 6: Isolator systems — Amendment 1149ISO 13408-7:2012Aseptic processing of health care products - Part 7: Alternative processes for medical devices andcombination products150ISO 14937:2009Sterilization of health care products - General requirements for characterization of a sterilizing agentand the development, validation and routine control of a sterilization process for medical devices151ISO 15883-1:2006/Amd 1:2014Washer-disinfectors - Part 1: General requirements, terms and definitions and tests152ISO 15883-2:2006Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermaldisinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils,glassware, etc.153ISO 15883-3:2006Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermaldisinfection for human waste containers (ISO 15883-3:2006)154ISO 15883-4:2018Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemicaldisinfection for thermolabile endoscopes155ISO 17665-1:2006Sterilization of health care products - Moist heat - Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices156ISO 10993-7:2008/AMD 1:2019Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment1: Applicability of allowable limits for neonates and infants157ISO 11137-1:2006, including Amd 1:2013 & Amd 2:2018
Sterilization of health care products - Radiation - Part 1: Requirements for development, validationand routine control of a sterilization process for medical devices158ISO 11137-2:2013Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose159ISO 11140-1:2014Sterilization of health care products - Chemical indicators - Part 1: General requirements160ISO 11607-1:2019Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterilebarrier systems and packaging systems161ISO 11737-1:2018Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population ofmicroorganisms on products162ISO 11737-2:2019Sterilization of health care products — Microbiological methods — Part 2: Tests of sterilityperformed in the definition, validation and maintenance of a sterilization process163ISO 13408-2:2018Aseptic processing of health care products - Part 2: Filtration164ISO 13408-3:2006Aseptic processing of health care products - Part 3: Lyophilization165ISO 13408-4:2005Aseptic processing of health care products - Part 4: Clean-in-place technologies166ISO 13408-5:2006Aseptic processing of health care products - Part 5: Sterilization in place167ISO 13408-7:2012Aseptic processing of health care products - Part 7: Alternative processes for medical devices andcombination products168ISO 14937:2009Sterilization of health care products - General requirements for characterization of a sterilizing agentand the development, validation and routine control of a sterilization process for medical devices169ISO 17665-1:2006
Sterilization of health care products - Moist heat - Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices170ISO 11737-2:2019Sterilization of health care products — Microbiological methods — Part 2: Tests of sterilityperformed in the definition, validation and maintenance of a sterilization process171ISO 13408-2:2018Aseptic processing of health care products -- Part 2: Sterilizing filtration172ISO 13408-5:2006Aseptic processing of health care products - Part 5: Sterilization in place173ISO 14937:2009Sterilization of health care products - General requirements for characterization of a sterilizing agentand the development, validation and routine control of a sterilization process for medical devices174ISO 14160:2011Sterilization of health care products - Liquid chemical sterilizing agentsfor single-use medical devices utilizing animal tissues and theirderivatives -- Requirements for characterization, development,validation and routine control of asterilization175ISO 17665-1:2006Sterilization of health care products -- moist heat -- part 1: requirements for the development,validation and routine control of a sterilization process for medical devices176ISO/TS 17665-2:2009Sterilization of health care products -- moist heat -- part 2: guidance on the application of iso 176651177ISO/TS 17665-3:2013Sterilization of health care products -- moist heat -- part 3: guidance on the designation of a medicaldevice to a product family and processing category for steam sterilization178ISO 25424:2018Sterilization of health care products -- low temperature steam and formaldehyde -- requirements fordevelopment, validation and routine control of a sterilization process for medical devicesQuality management and general corresponding aspects for medical devices Standards179ISO 13408-3:2006Aseptic processing of health care products - Part 3: Lyophilization
180ISO 13408-4:2005Aseptic processing of health care products - Part 4: Clean-in-place technologies181ISO 13408-5:2006Aseptic processing of health care products - Part 5: Sterilization in place182ISO 13408-7:2012Aseptic processing of health care products - Part 7: Alternative processes for medical devices andcombination products183ISO 14971:2019Medical devices — Application of risk management to medical devices184ISO 13408-1:2008, including Amd 1:2013Aseptic processing of health care products - Part 1: General requirements185ISO 13408-2:2018Aseptic processing of health care products -- Part 2: Sterilizing filtration186ISO 13408-3:2006Aseptic processing of health care products - Part 3: Lyophilization187ISO 13408-4:2005Aseptic processing of health care products - Part 4: Clean-in-place technologies188ISO 13408-7:2012Aseptic processing of health care products - Part 7: Alternative processes for medical devices andcombination products189ISO 80369-7:2016Small-bore connectors for liquids and gases in healthcare applications -- part 7: connectors forintravascular or hypodermic applications190ISO 13485 :2016Medical devices -- Quality management systems -- Requirements for regulatory purposes191ISO 15223-1:2017Medical devices — Symbols to be used with medical device labels, labelling and information to besupplied — Part 1: General requirementsClinical laboratory testing and in vitro diagnostic test systems Standards
192ISO 15197:2013In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testingin managing diabetes mellitus193ISO 18113-1:2009In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1:Terms, definitions and general requirements194IEC 61010-2-101:2018Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2101: Particular requirements for in vitro diagnostic (IVD) medical equipment195IEC 61326-2-6:2012Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6:Particular requirements - In vitro diagnostic (IVD) medical equipmentElectrical equipment in medical practice196IEC 60118-13:2019Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement forelectromagnetic immunity to mobile digital wireless devices197IEC 60522:1999Determination of the permanent filtration of X-ray tube assemblies198IEC 60580:2019Medical electrical equipment - Do
42 ISO 80601-2-12:2015 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators 43 ISO 80601-2-70:2017 Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essentia
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(Note: This MDS 3.0 Draft contains only the new/revised items that are being tested in the field trial. Some retained administrative items are not included in the study form in order to protect resident privacy.) DRAFT VERSION - 7/31/2006. INTRODUCTION: THE MDS 3.0 EVALUATION STUDY INTRODUCTION TO THE MDS 3.0 This revision of the Minimum Data Set for Nursing Homes (MDS 3.0) builds on lessons .
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