Medical Devices And Medical Systems — Essential Safety .
ASTM/WD.3 xxxxx-1 ASTM 2008 – All rights reservedASTM final F-2761Chair: Julian M. Goldman, MDContact details: www.jgoldman.infoThis document is for use by ASTM F29.21 committee in preparation of ASTM standard F2761-2009The completed standard, once published, can be obtained from ASTM International www.astm.orgMedical Devices and Medical Systems — Essential safety requirements forequipment comprising the patient-centric integrated clinical environment(ICE) — Part 1: General requirements and conceptual modelÉlément introductif — Élément central — Partie 1: Titre de la partieDocument type: International StandardDocument subtype:Document stage: (50) finalDocument language: E
ASTM/WD.3 xxxxx-1 ASTM 2008 – All rights reserved12Copyright notice345678This ASTM document is a working draft or committee draft and includes content that is copyright-protected byASTM. While the reproduction of working drafts or committee drafts in any form for use by participants in thestandards development process is permitted without prior permission, neither this document nor any extractfrom it may be reproduced, stored or transmitted in any form for any other purpose without prior writtenpermission from ASTM (with exceptions as noted by agreement with the CIMIT/MGH MD PnP programaffiliated drafting committee).9Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.10Violators may be prosecuted.Document type: International StandardDocument subtype:Document stage: (50) finalDocument language: E
WORKING DRAFTASTM final F-276111Contents12Foreword . vii13Introduction . ix141* Scope . 1152Normative references. 1163Terms and definitions . .4*ICE conceptual functional model . 5Overview . 5ICE NETWORK CONTROLLER . 7* General. 7ICE NETWORK CONTROLLER interfaces . 7* External interface . 8* Forensic data logging. 9*ICE SUPERVISOR . 9* ICE EQUIPMENT INTERFACE . 926272829303155.15.25.35.45.5General requirements . 9RISK MANAGEMENT PROCESS . 9* ICE EQUIPMENT INTERFACE qualification test . 10Software . 10Communication management . 10ALARM SYSTEM . 11323334Annex A (informative) Guidance and rationale . 12A.1General guidance . 12A.2Rationale and guidance for particular clauses and subclauses. 123536373839404142434445464748Annex B (informative) Clinical context and clinical scenarios. 20B.1Purpose and introduction. 20B.1.1 Purpose . 20B.1.2 Methodology . 20B.1.3 Clinical scenario . 21B.1.4 Clinical concept of operations (CConOps) . 21B.2Clinical Examples . 21B.2.1 Safety Interlocks. 21B.2.2 Synchronization with safety interlock . 23B.2.3 Process control (workflow) . 24B.2.4 Smart alarm system . 24B.2.5 Decision support . 25B.2.6 Physiological Closed Loop Control (PCLC). 26B.2.7 Medical Device Plug-and-Play Interoperability (MD PnP). 2749Annex C (informative) Reference to the Essential Principals. 2950Annex D (informative) Terminology – Alphabetized index of defined terms . Error! Bookmark not defined.51Bibliography . 31v ASTM 2008 – All rights reservedPage
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ASTM/WD.2 xxxxx-1 ASTM 2008 – All rights reserved53Foreword5455Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. ASTM shall not be held responsible for identifying any or all such patent rights.5657585960ASTM 2761 was prepared by ASTM Committee F-29, Anaesthetic and Respiratory Equipment, Subcommittee21, Devices in the integrated clinical environment. This work is based in part on concepts developed within the[8]CIMIT Program on Interoperability and the Massachusetts General Hospital program on Medical Device “Plugand-Play” Interoperability (“MD PnP” program, founded 2004) with information disseminated through[9] [28],[37]publications, workshops, and website.61This is the first edition.626364ASTM 2761 is expected to part of a series of standards, under the general title Medical Devices and MedicalSystems — Essential principles of safety and performance for equipment comprising the patient-centricintegrated clinical environment (ICE):656667 ASTM F-2761, Medical Devices and Medical Systems — Essential principles of safety and performance forequipment comprising the patient-centric integrated clinical environment (ICE) Part 1: General requirementsand conceptual model (this standard)686970 ASTM F-——, Medical Devices and Medical Systems — Essential principles of safety and performance forequipment comprising the patient-centric integrated clinical environment (ICE) Part 2: Requirements fornetwork control and equipment interface717273 ASTM F-——, Medical Devices and Medical Systems — Essential principles of safety and performance forequipment comprising the patient-centric integrated clinical environment (ICE) Part 3: Requirements fordevice models747576 ASTM F-——, Medical Devices and Medical Systems — Essential principles of safety and performance forequipment comprising the patient-centric integrated clinical environment (ICE) Part 4: Requirements forsupervision777879 ASTM F-——, Medical Devices and Medical Systems — Essential principles of safety and performance forequipment comprising the patient-centric integrated clinical environment (ICE) Part 5: Requirements forsafe and reliable integration80In this standard, the following print types are used:81–Requirements and definitions: roman type.82–Test specifications: italic type.8384–Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normativetext of tables is also in a smaller type.85–8687In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of theconditions is true.TERMS DEFINED IN THIS STANDARD OR AS NOTED: SMALL CAPS.vii ASTM 2008 – All rights reserved
ASTM/WD.2 xxxxx-1 ASTM 2008 – All rights reserved88For the purposes of this standard, the auxiliary verb:89-9091“should” means that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this standard;92-9394Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with anasterisk (*).9596979899100NOTEAttention is drawn to the fact that equipment manufacturers and testing organizations may need a transitional periodfollowing publication of a new, amended or revised publication in which to make products in accordance with the newrequirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that thecontent of this publication not be adopted for mandatory implementation nationally earlier than 3 years from the date ofpublication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already inproduction.“shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;“may” is used to describe a permissible way to achieve compliance with a requirement or test.101viii ASTM 2008 – All rights reserved
ASTM/WD.2 xxxxx-1 ASTM 2008 – All rights L DEVICES are essential for the practice of modern medicine. Some MEDICAL DEVICES utilize opennetworking standards for communication to provide data for the electronic health record. However, unlike theinteroperable “plug-and-play” environment of modern computers and consumer electronics, most acute careMEDICAL DEVICES are not designed to interoperate. MEDICAL DEVICES typically utilize proprietary protocols forsystem integration. These approaches do not provide the comprehensive integration capabilities necessary forsafe, cross-MANUFACTURER MEDICAL DEVICE integration for data communication and MEDICAL DEVICE control forthe care of a single high acuity PATIENT.110111112113114This standard series establishes the general principles for the design, verification, and validation of a modelbased integration system that enables the creation of an INTEGRATED CLINICAL ENVIRONMENT intended to facilitatecross-MANUFACTURER MEDICAL DEVICE interoperability. This series of standards focuses especially oncommunication of PATIENT data and on equipment command and control, as well as on the functionalitynecessary for the seamless creation of an INTEGRATED CLINICAL ENVIRONMENT.115116117The approach defined and described by this series of standards for the INTEGRATED CLINICAL ENVIRONMENT (ICE)includes provisions for error resistance, and continual improvements in PATIENT safety, treatment efficacy and[30]workflow efficiency based on device interoperability.118ix ASTM 2008 – All rights reserved
WORKING DRAFTASTM final F-2761122Medical Devices and Medical Systems — Essential safetyrequirements for equipment comprising the patient-centricintegrated clinical environment (ICE) — Part 1: Generalrequirements and conceptual model1231124125126127128129130This standard specifies general requirements, a model and framework for integrating equipment to create aINTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessaryfor the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from differentMANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standardestablishes requirements for a medical system that is intended to have greater error resistance and improvedPATIENT safety, treatment efficacy and workflow efficiency than can be achieved with independently used[8]MEDICAL DEVICES.131132This series of standards establishes requirements for design, verification, and validation processes of a modelbased integration system for an INTEGRATED CLINICAL ENVIRONMENT.133134This series of standards is intended to define the requirements essential for safety and thereby facilitateregulatory acceptance.135136NOTEAnnex B.1372138139140141142143The following referenced documents are indispensable for the application of this document. The way in whichthese referenced documents are cited in normative requirements determines the extent (in whole or in part) towhich they apply. For dated references, only the edition cited applies. However, parties to agreements basedon this standard are encouraged to investigate the possibility of applying more recent editions of the normativedocuments indicated below. For undated references, the latest edition of the referenced document (includingany amendments) applies.144ISO 14971:2007, Medical devices -- Application of risk management to medical devices145146147IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic safety andessential performance – Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems148IEC 62304:2006, Medical device software – Software life cycle processes119120121* ScopeThese requirements were derived to support the clinical scenarios or clinical concepts of operations described inNormative references1 ASTM 2008 – All rights reserved
ASTM/WD.2 xxxxx-1 ASTM 2008 – All rights reserved149IEC 80001:——1) , Application of risk management for IT-networks incorporating medical devices1503151152For the purposes of this document, the definitions given in ISO 14971:2007, IEC 60601-1-8:2006 and thefollowing apply.1531541551563.1157[IEC 60601-1:2005, definition 3.10, modified]1581591601611623.2163EXAMPLE 1Remote OPERATOR-interface for an ICE SUPERVISOR.164EXAMPLE 2A 'central station' reviewing the information from multiple PATIENTS.1651661671683.3* DEVICE MODELrepresentation of the capabilities of ICE-COMPATIBLE EQUIPMENT that includes the information needed toqualitatively and quantitatively describe, control and monitor its operation169NOTE 1The MANUFACTURER chooses the capabilities that are exposed through the ICE EQUIPMENT INTERFACE.170NOTE 2ASTM F-—— (Part 3) is intended to specify the requirements for a DEVICE MODEL.1711721733.4174175NOTEESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or degradation wouldresult in an unacceptable RISK.176[IEC 60601-1:2005, definition 3.27]1771781791803.5Terms and definitionsBASIC SAFETYfreedom from unacceptable RISK directly caused by physical hazards when a MEDICAL DEVICE is used undernormal condition and single fault conditionCECCLINICAL ENVIRONMENT COORDINATORequipment, remote from the INTEGRATED CLINICAL ENVIRONMENT,CLINICAL ENVIRONMENTSthat can control one or more INTEGRATEDESSENTIAL PERFORMANCEperformance necessary to achieve freedom from unacceptable RISKFULLY COMPLIANTtype of ICE EQUIPMENT INTERFACEthe ICE NETWORK CONTROLLER1)where the DEVICE MODEL is exported through the ICE EQUIPMENT INTERFACE toTo be published.2 ASTM 2008 – All rights reserved
ASTM/WD.2 xxxxx-1 ASTM 2008 – All rights reserved1811821831841853.6* ICE186NOTE 1187188NOTE 2When supporting ICE functionality, the components that comprise an ICE typically function interdependently; theydo not function independently.189190NOTE 3191192193NOTE 4Unlike a "Medical Electrical System" in IEC 60601-1:2005, ICE is presumed to comprise equipment from morethan one MANUFACTURER. There is not necessarily a MANUFACTURER of the ICE, since combining equipment to form an ICE isthe labeled intent of this equipment.1941951963.7ICE-COMPATIBLE EQUIPMENTMEDICAL DEVICE or other electrical equipment with an ICE EQUIPMENT INTERFACE1971981993.8200201NOTEThe ICE EQUIPMENT INTERFACE typically is an interface between software processes and is not an interfacebetween the OPERATOR and ICE-COMPATIBLE EQUIPMENT.2022032042053.92062072082093.10210NOTE 1211212NOTE 2Application logic can include clinical algorithms, distributed control integration and clinical decision supportalgorithms.2132142152163.11217[IEC 14971:2007, definition 2.5, modified]2182192202212223.12INTEGRATED CLINICAL ENVIRONMENTenvironment that combines interoperable heterogeneous MEDICAL DEVICES and other equipment integrated tocreate a medical system for the care of a single high acuity PATIENTAn ICE can provide data acquisition, safety interlocks, system integration and distributed closed loop control.AnICEtypically consists of anICE SUPERVISOR,anICE NETWORK CONTROLLERand one or more pieces ofICE-COMPATIBLE EQUIPMENT.ICE EQUIPMENT INTERFACEpart of ICE-COMPATIBLE EQUIPMENT thatICE NETWORK CONTROLLERpart of an ICE that providesDEVICE modelprovides the interface to the ICE NETWORK CONTROLLERcommunication between ICE-COMPATIBLE EQUIPMENT and the rest of the ICE, using theICE SUPERVISORpart of an ICE that provides a platform for functional integration between ICE-COMPATIBLE EQUIPMENTICE NETWORK CONTROLLER and can provide application logic and an OPERATOR interfacevia theAn ICE SUPERVISOR is equipment and software, not a person.INTENDED USEuse for which a product, process or service is intended according to the specifications, instructions andinformation provided by the MANUFACTURERMANUFACTURERnatural or legal person with responsibility for the design, manufacture, packaging, or labeling of a MEDICALDEVICE, assembling a medical system, or adapting a MEDICAL DEVICE or a medical system, regardless of whetherthese operations are performed by that person or on that person's behalf by a third party3 ASTM 2008 – All rights reserved
ASTM/WD.2 xxxxx-1 ASTM 2008 – All rights reserve
ASTM F-——, Medical Devices and Medical Systems — Essential principles of safety and performance for 72 equipment comprising the patient-centric integrated clinical environment (ICE) Part 3: Requirements for 73 device models 74 ! ASTM F-——, Medical Devices and Medical Systems
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GHTF/SG1/N40:2006 Principles of Conformity Assessment for Medical Devices. GHTF/SG1/N41:2005 Essential Principles of Safety and Performance of Medical Devices. GHTF/SG1/N43:2005 Labelling for Medical Devices. 4.0 Definitions Active medical device: Any medical device, operation of whic h depends on a source of electrical
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of medical devices recognized by EFDA as low-risk products. 3 SCOPE This guideline is applicable to all class A In vitro Diagnostic (IVD) Medical devices and class I medical devices other than IVD included in the low risk medical devices listed in this guideline. It is not applicable to all Sterile and most Measuring devices. 4 DEFINITIONS
single-use medical devices (Article 17) 3; and certain devices with no intended medical purpose (Annex XVI). The MDR also covers internet sales of medical devices and med - ical devices used for diagnostic or therapeutic services offered at a distance (Article 6). The MDR introduces a
Class Is/Im/Ir devices 2 Class IIa devices 4 Class IIb Annex VIII rule 12 devices 8 Class IIb implantable – Well-Established Technologies (WET) 10 Class IIb non-implantable non rule 12 devices (non WET) 10 Class IIb implantable devices (excluding WET) 14 Class III non-implantable devices 16 Class III implantable devices 18 Custom-made Class III implantable .
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Abrasive jet machining (AJM), also called abrasive micro blasting, is a manufacturing process that utilizes a high-pressure air stream carrying small particles to impinge the workpiece surface for material removal and shape generation. The removal occurs due to the erosive action of the particles striking the workpiece surface. AJM has limited material removal capability and is typically used .
