Ansi Aami Iec Tir80002 1 2009 Medical Device Software-PDF Free Download

AAMI ANSI/AAMI HE75-2009 (R2018), Human factors engineering - Design of medical devices Approved: 8/10/2018 AAMI ANSI/AAMI ID54-1996 (R2012), Enteral feeding set adapters and connectors Approved: 1/17/2012 AAMI ANSI/AAMI NS28-1988 (R2015), Intracranial pressure monitoring devices

IEC 61215 IEC 61730 PV Modules Manufacturer IEC 62941 IEC 62093 IEC 62109 Solar TrackerIEC 62817 PV Modules PV inverters IEC 62548 or IEC/TS 62738 Applicable Standard IEC 62446-1 IEC 61724-1 IEC 61724-2 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/

IEC has formed IECRE for Renewable Energy System verification - Component quality (IEC 61215, IEC 61730, IEC 62891, IEC 62109, IEC 62093, IEC 61439, IEC 60947, IEC 60269, new?) - System: - Design (IEC TS 62548, IEC 60364-7-712, IEC 61634-9-1, IEC 62738) - Installation (IEC 62548, IEC 60364-7-712)

Writing Human Factors Plans & Reports for Medical Technology Development pReVIeW COpY This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. For a complete copy of this AAMI document contact AAMI at 1- 77-2-22 or visit www.aami.org. PREVIEW COPY This is a preview edition .

IEC 61869-9, IEC 62351 (all parts), IEC 62439-1:2010, IEC 62439-3:2010, IEC 81346 (all parts), IEC TS 62351- 1, IEC TS 62351- 2, IEC TS 62351- 4, IEC TS 62351- 5, Cigre JWG 34./35.11, IEC 60044 (all parts), IEC 60050 (all parts), IEC 60270:2000, IEC 60654-4:1987, IEC 60694:1

AAMI/ANSI HE75 : Human Factors Engineering – Design of Medical Devices : 2009 AAMI/ANSI/IEC 62366-1 : Medical Devices – Part 1: Application of Usability Engineering to Medical Devices : 2015 AAMI/ANSI/IEC 62304 : Medical Device Software – Software Life Cycle Processes : 2006

(Amendment 1) (supplement to ANSI/AAMI/ISO 10993-12-2002) Order from: AAMI Send comments (with copy to BSR) to: Hillary Woehrle, AAMI; hwoehrle@aami.org Single copy price: 25.00 Amends ISO 10993-12: 2002. ASME (American Society of Mechanical Engineers) New Standards BSR/ASME

ANSI/AAMI HE75-2009 (R2013), Human factors engineering - Design of medical devices (reaffirmation of ANSI/AAMI HE75-2009) PINS Date: Public Review Start: Jul 12, 2013 Approval Date: Nov 26, 2013 ANSI/AAMI ID26-2004 (R2013), Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers

The new IEC 61439 series is expected to have a similar structure to IEC 60439 with several new additions*: IEC 60439 IEC 61439 Series IEC 61439-1 General rules IEC 61439-2 Power switchgear and controlgear assemblies IEC 61439-6 Busbar trunking systems IEC 61439-3 Distribution boards IEC 61439-4 Assemblies for construction sites IEC 61439-5

Send comments (with copy to psa@ansi.org) to: Heather Sakellariou, (847) 664-2346, Heather.Sakellariou@ul.com Comment Deadline: August 26, 2013 AAMI (Association for the Advancement of Medical Instrumentation) Reaffirmation BSR/AAMI HE75-2009 (R201x), Human factors engineering - Design of medical devices (reaffirmation of ANSI/AAMI HE75-2009)

Access more than 200 comprehensive national and international standards and . technical documents—including sterilization, dialysis, biological evaluation of . of dialysis fluid standards as replacements for the ANSI/AAMI 2014 versions, which have been technically revised. AAMI also . This is the American adoption of the IEC 60601-1 .

ANSI/AAMI/IEC 62304:2006 Medical device software— Software life cycle processes PREVIEW COPY This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing dec ision. For a complete copy of this AAMI document, .

IEC 61968-4 IEC 61968- 6 IEC 61968-7 IEC 61968-8 IEC 61968-9 Applicable parts of IEC 61968 Series Network Operation (NO) IEC 61968-3 Operational Planning & Optimization (OP) IEC 61968-5 Bulk Energy Management (EMS) IEC 61970 & Applicable parts of IEC 61968 Series External Systems: Customer Account Management (ACT) Financial (FIN) Business .

IEC 60634-1 IEC 60050-826 IEC 60364-4-41 IEC 60364-4-42 IEC 60364-5-52 IEC/DIS 64(CO)9173 IEC 60204-32 IEC 60529-1989; IEC 60529 IEC 60529 Accident prevention regulation "Electrical systems and apparatus" Accident prevention regulatio

IEC 60034-7 IEC 60034-8 IEC 60034-9 IEC 60034-11 IEC 60034-12 IEC 60034-14 IEC 60034-30 IEC 60085 IEC 60038 IEC 60072 CEMER motors comply with the relevant European and International norms and regulations, in particular wi

The new IEC 61439 series is expected to have a similar structure to IEC 60439 with several new additions*: IEC 60439 IEC 61439 Series IEC 61439-1 General rules IEC 61439-2 Power switchgear and controlgear assemblies IEC 61439-6 Busbar trunking systems IEC 61439-3 Distribution boards IEC 61439-4 Assem

EMC: EN 55015 IEC 61000-3-3 IEC 61547 IEC 61000-4-2 IEC 61000-4-3 IEC 61000-4-6 IEC 61000-4-8 IEC 61000-4-11 Transient protection: 6kV/3kA combination wave, as per IEEE C62.41, line-line and line-ground IEC 61000-4-5 IEC 61000-4-4 THD: IEC 55015 20% @ 100-2

IEC 60634-1 IEC 60050-826 IEC 60364-4-41 IEC 60364-4-42 IEC 60364-5-52 IEC/DIS 64(CO)9173 IEC 60204-32 IEC 60529-1989; IEC 60529 IEC 60529 Accident prevention regulation "Electrical systems and apparatus" Accident prevention regulation "Cranes" Safety instructions "Monorails"

IEC 60060 / IEC 60071 High voltage test techniques./ Insulation coordination IEC 60099-4/ IEC 60859 Surge arresters/ Cable connections for GIS. IEC 60137 Bushings for alternating voltage above 1000V. IEC 60255/ IEC 60265 Electrical Relays./High voltage switches. IEC 60270 Partial discharge measurement. IEC 60376 / IEC 60480 Specification and .

AAMI/ANSI HE75:2009 Human factors engineering - Design of medical devices ANSI/AAMI/IEC 62366-1:2015 Medical devices –Part 1: Application of usability engineering to medical devices IEC/TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (reaffirmation of ANSI/AAMI/IEC 60601-2-25-2012): 1/6/2017 ANSI/AAMI/IEC 60601-2-27-2011 (R2016), Medical electrical equipment - Part 2

ANSI/BHMA certiied A156.2-2011 Exceeds 400,000 ANSI cycles Medium traic ANSI/BHMA certiied A156.5-2010 Exceeds 150,000/250,000 ANSI cycles High traic, heavy-duty ANSI/BHMA certiied A156.2-2011 Exceeds 1,000,000 ANSI cycles High traic ANSI/BHMA certiied A156.2-2011 Exceeds 1,000,000 ANSI cycles Heavy-duty traic ANSI/

ANSI/BHMA certiied A156.2-2011 Exceeds 400,000 ANSI cycles Medium traic ANSI/BHMA certiied A156.36-2010 Exceeds 150,000/250,000 ANSI cycles High traic, heavy-duty ANSI/BHMA certiied A156.2-2011 Exceeds 1,000,000 ANSI cycles High traic ANSI/BHMA certiied A156.2-2011 Exceeds 1,000,000 ANSI cycles Heavy-duty traic ANSI/

WOOD LADDER ANSI A14.1 STEEL LADDER ANSI A14.7 SPECIAL DUTY LADDER ANSI A14.10 METAL LADDER ANSI A14.2 FIBERGLASS LADDER ANSI A14.5 STAGE PLATFORM ANSI A10.8 ROLLING SCAFFOLD ANSI A10.8 ATTIC LADDER ANSI A14.9 In addition, ANSI codes have established a Duty Rating

ANSI B16.10 /ANSI B16.9 ASTM A 106 Gr B ASTM A 234 WPB ANSI B16.5 ASTM A 105 Tee Cast steel ANSI B16.5 ASTM A 216 WCB ANSI B16.5 (*) ASTM A 216 WCB Concentric & Eccentric Reducers ANSI B16.9 ASTM A 234 WPB ANSI B16.5 ASTM A 105 Reducing flange ANSI

Epson FX-1180 Proprinter III XL MTPL Character Set HP Roman-8 DEC Multinat’l Italic Code Page 437 Code Page 437 OCR-A ANSI ANSI ANSI ANSI ANSI OCR-B ANSI DIN ANSI ANSI ANSI Auto CR OFF OFF ON ON ON Line Wrap OFF OFF ON ON ON Wrap LF OFF OFF ON ON ON Code 7F Fill Fill Del Char Ignore Del Bu

Protective Apparel and Drapes Intended for use in Health Care Facilities. ANSI/AAMI PB70:2012. Arlington, VA: AAMI. AAMI Level guide 4. Key features like wrist, neck and back style can vary from gown to gown. Use this style guide to understand the differences. Wrist style options Neck style options Back style options

Rated voltage : 15.8kV (ANSI)/17.5kV (IEC) Rated current : 7500A Rated frequency : 50/60Hz Rated breaking current : 63kA Standards : IEEE (ANSI) C37.013, IEC 60694, IEC 60298, IEC 60129, IEC 60044-1 & -2, IEC 60099-4, IEC 60358 The Investors’ and

IEC 61099 9.2 OECD 301 IEC 60156 IEC 60247 IEC 62697 IEC 60814 IEC 62021.3 IEC 61125C IEC 62621.3 ISO 3104 IEC 60247 1.0 275 300 -10 0.96 15 50 500 bright and clear readily biodeg radable 30 20 35 0 0.20 4.0 non-corrosive 2 00 0.06 not detectable 250 300 -10 0.96 15 0 clear, free from .

02 Basics of IEC 62446 Overview of sub standards . IEC 62446. IEC 60364 (all parts) IEC 60364-6 IEC 60364-7-712:2002 . IEC/TR 60755:2008 . IEC 61557 (all parts) IEC 61730-1 - Clause 4 - System documentation requirements - Clause 5 - Verification . 4.1 General . 4.2 System data . 4.3 Wiring diagram . 4.4 Datasheets . 4.5 Mechanical design .

IEC 61000-4-5: 2005 IEC 61000-4-5: 2005 IEC 61000-4-6: 2008 IEC 61000-4-6: 2008 IEC 61000-4-8: 2009 IEC 61000-4-8: 2009 IEC 61000-4-11: 2004 IEC 61000-4-11: 2004 IEC 61000-4-12: 2006 VCCI VCCI OpShield is now available with or withou

IEC 417, No.5007 Off (Supply) IEC 417, No.5008 Earth (ground) IEC 417, No.5017 Protective earth (ground) IEC 417, No.5019 Frame or chassis IEC 417, No.5020 Equipotentiality IEC 417, No.5021 Direct current IEC 417, No.5031 Alternating current IEC 417, No.5032 Both direct and alternating current IEC 417, No.5

IEC 60364‐6 IEC 61010 – laboratory u IEC 61557 – d.c. IEC 61724‐1 IEC 61724‐2 IEC 61724‐3 IEC 61730‐2 IEC 62446‐1 maintenanc inspection IEC 62548 – erms and power (P) neous prod wer is the r t power (S or two‐term er sinusoida pe – descr

IEC 60364‐6 IEC 61010 – laboratory u IEC 61557 – d.c. IEC 61724‐1 IEC 61724‐2 IEC 61724‐3 IEC 61730‐2 IEC 62446‐1 maintenanc inspection IEC 62548 – erms and ule – PV mo power (P) neous prod wer is the r t power (S or two‐term er sinusoida p

Gas-insulated metal-enclosed switchgear IEC 62271-203 Disconnecting and earthing switches IEC 62271-102 Circuit breakers IEC 62271-103 High-voltage contactors and motor starters IEC 62271-106 Surge arresters IEC 60099-4 Current transformers IEC 60044-1 Insulators IEC 61109/60383/60168 Environmental testing IEC 60068 Insulated bushings 1 kV IEC .

Alternating Locations When a power failure occurs, transformers must be . Gas-insulated switchgear to IEC 62271-203 Plug-in bushings to IEC 60137 Surge Arrester IEC 60099-4 Bushing IEC 60137 Dummy Plug Connector IEC 60840 / IEC 62067 Transformer Test: IEC 60137 Dimensions: EN 50299 Gas-Insulated Switchgear Test: IEC 62271-203 Dimensions: IEC .

BSR/AAMI/IEC 62366-2007 (R201x), Medical devices - Application of usability engineering to medical devices (reaffirmation of ANSI/AAMI/IEC 62366-2007) This standard describes a usability engineering process, and provides guidance on how to implement and

adopts the IEC 60601-1 standard. It is hoped that this document will be useful for users of the IEC 60601 series. Suggestions for improving this document are invited. Comments and suggestions should be forwarded to the AAMI Standards Program, AAMI, 901 N. Glebe Road, Suite 300, Arl

ANSI/BHMA A156.15 Closer Holder Release Devices ANSI/BHMA A156.17 Self-Closing Hinges and Pivots ANSI/BHMA A156.18 Materials & Finishes ANSI/BHMA A156.19 Power Assist & Low Energy Power Operated Doors ANSI/BHMA A156.21 Thresholds ANSI/BHMA A156.22 Door Gasketing Systems ANSI/BHMA A156.23 E

ANSI/BHMA certified A156.2-2011 Exceeds 400,000 ANSI cycles Medium traffic ANSI/BHMA certified A156.5-2010 Exceeds 150,000/250,000 ANSI cycles High traffic, heavy-duty ANSI/BHMA certified A156.2-2011 Exceeds 1,000,000 ANSI cycles High traffic ANSI/BHMA certified A156.2-2011 Exceeds 1,000,000 ANSI cycles He