ISO 14708-1 : 2014

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IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER

Publisher: International Organization for Standardization

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations (optional)
5 General requirements for ACTIVE IMPLANTABLE
   MEDICAL DEVICES
6 Requirements for particular ACTIVE IMPLANTABLE
   MEDICAL DEVICES
7 General arrangement of the packaging
8 General markings for ACTIVE IMPLANTABLE
   MEDICAL DEVICES
9 Markings on the SALES PACKAGING
10 Construction of the SALES PACKAGING
11 Markings on the STERILE PACK
12 Construction of the NON-REUSABLE PACK
13 Markings on the ACTIVE IMPLANTABLE MEDICAL
   DEVICE
14 Protection from unintentional biological effects
   being caused by the ACTIVE IMPLANTABLE
   MEDICAL DEVICE
15 Protection from HARM to the patient or user caused
   by external physical features of the ACTIVE IMPLANTABLE
   MEDICAL DEVICE
16 Protection from HARM to the patient caused by electricity
17 Protection from HARM to the patient caused by heat
18 Protection from ionizing radiation released or emitted from
   the ACTIVE IMPLANTABLE MEDICAL DEVICE
19 Protection from unintended effects caused by the ACTIVE
   IMPLANTABLE MEDICAL DEVICE
20 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from damage caused by external defibrillators
21 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from changes caused by electrical fields applied
   directly to the patient
22 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from changes caused by miscellaneous medical
   treatments
23 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from mechanical forces
24 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from damage caused by electrostatic discharge
25 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from damage caused by atmospheric pressure
   changes
26 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from damage caused by temperature changes
27 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from electromagnetic nonionizing radiation
28 Accompanying documentation
Annex A (informative) - General guidance and rationale
Annex B (informative) - Relationship between the fundamental
        principles in ISO/TR 14283:2004 and the clauses
        of this part of ISO 14708
Bibliography

Abstract - (Show below) - (Hide below)

This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices.

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Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150
Supersedes	ISO/DIS 14708-1 : 60.00 (2014) ISO 14708-1 : 2000

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
AAMI ISO 14708-1 : 2014	Identical
NEN ISO 14708-1 : 2014	Identical
AS ISO 14708.1:2015	Identical
DS/ISO 14708-1 : 2014	Identical
IS/ISO 14708 : Part 1 : 2019	Identical
NBR ISO 14708-1 : 2016	Identical
DS/ISO 14708-1 : 2014	Identical
NEN ISO 14708-1 : 2014	Identical
IS/ISO 14708 : Part 1 : 2019	Identical
AAMI ISO 14708-1 : 2014	Identical
BIS IS/ISO 14708-1 : 2000	Identical
NBR ISO 14708-1 : 2016	Identical
GOST R ISO 14708-1 : 2012	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

BS EN 60601-2-31 : 2008	MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
AAMI ISO 27186 : 2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
16/30339831 DC : 0	PD ISO/TR 14283 - IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE
08/30192448 DC : DRAFT DEC 2008	BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
CSA C22.2 No. 60601.1 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
BS PD CEN ISO/TS 16775 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
AAMI CI86 : 2017	COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING
BS ISO 27185 : 2012	CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
08/30191626 DC : DRAFT OCT 2008	BS ISO 27186 - ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
BS PD ISO/TS 10974 : 2012	ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE
CSA C22.2 No. 60601-2-31 : 2009 : INC : AMD 1 : 2014 : (R2019)	MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
AAMI TIR41 : 2011	ACTIVE IMPLANTABLE MEDICAL DEVICES - GUIDANCE FOR DESIGNATION OF LEFT VENTRICLE AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD CONNECTORS AND PULSE GENERATOR CONNECTOR CAVITIES FOR IMPLANTABLE PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
BS PD ISO/TR 21730 : 2007	HEALTH INFORMATICS - USE OF MOBILE WIRELESS COMMUNICATION AND COMPUTING TECHNOLOGY IN HEALTHCARE FACILITIES - RECOMMENDATIONS FOR ELECTROMAGNETIC COMPATIBILITY (MANAGEMENT OF UNINTENTIONAL ELECTROMAGNETIC INTERFERENCE) WITH MEDICAL DEVICES
15/30316128 DC : 0	BS EN ISO 14708-3 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
10/30195946 DC : DRAFT DEC 2010	BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
BS ISO 27186 : 2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
07/30165025 DC : 0	BS EN 60601-2-31 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
CSA C22.2 No. 60601-2-31 : 2009 : R2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
AAMI ISO 14708-4 : 2008 : R2011	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
CSA C22.2 No. 60601-2-31 : 2009	MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
AAMI ISO 14708-4 : 2008	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
ASTM F 2401 : 2016 : REDLINE	Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
ISO 14708-2 : 2012	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2: CARDIAC PACEMAKERS
SR CEN ISO/TS 16775:2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
ISO/IEC TR 20017 : 2011	INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - ELECTROMAGNETIC INTERFERENCE IMPACT OF ISO/IEC 18000 INTERROGATOR EMITTERS ON IMPLANTABLE PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
AAMI ISO 27185 : 2012	CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
AAMI ISO TIR 16775 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
AAMI ISO 14708-3 : 2017	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
AAMI ISO 14708-5 : 2010	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
I.S. EN 60601-2-31:2008	MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
ISO 14708-4 : 2008(R2013)	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
ISO 14708-3 : 2017	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
CSA ISO/IEC TR 20017 : 2014(R2019)	INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - ELECTROMAGNETIC INTERFERENCE IMPACT OF ISO/IEC 18000 INTERROGATOR EMITTERS ON IMPLANTABLE PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
ISO 14708-6 : 2010	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 6: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDING IMPLANTABLE DEFIBRILLATORS)
AAMI ISO TIR 10974 : 2012	ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE
ASTM F 3020 : 2016	Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security
CSA C22.2 No. 60601-2-31 : 2009(R2019)	MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
ISO 14708-5 : 2010	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
ISO 27185 : 2012(R2017)	CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
ISO TS 10974 : 2012	ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE
ISO 27186 : 2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
ASTM F 3278 : 2017	Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security
AAMI ES60601-1 : 2005	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
AAMI ES60601-1 : 2005	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
AAMI ISO 14708-4 : 2008	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
ISO TR 21730 : 2007	HEALTH INFORMATICS - USE OF MOBILE WIRELESS COMMUNICATION AND COMPUTING TECHNOLOGY IN HEALTHCARE FACILITIES - RECOMMENDATIONS FOR ELECTROMAGNETIC COMPATIBILITY (MANAGEMENT OF UNINTENTIONAL ELECTROMAGNETIC INTERFERENCE) WITH MEDICAL DEVICES
AAMI ES60601-1 : 2005 : R2012	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
IEC 60601-2-31 : 2.1	MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
EN 60601-1:2006/A1	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005)
BS EN 60601-1 : 2006	MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
IEC 60601-1:2005+AMD1:2012 CSV	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
ISO/TS 16775 : 2014(R2018)	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
UNE EN 60601-1 : 2008	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
EN 60601-2-31 : 2008 AMD 1 2011	MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
UNE EN 60601-1 : 2008	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

Standards Referencing This Book - (Show below) - (Hide below)

IEC 62127-1 : 1.1	ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ
ISO 11137-1:2006(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
IEC 60068-2-27 : 4.0	ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK
IEC 60601-1:2005+AMD1:2012 CSV	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
EN 45502-2-2 : 2008 COR 2009	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
ISO 13485 : 2016(R2020)	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
EN 60068-2-64 : 2008	ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
ISO 14937 : 2009(R2015)	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN 50061 : 88 AMD 1 95	SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
IEC 60068-2-64 : 2.0	ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
IEC 62366 : 1.1	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
ISO 11135-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO TR 14283 : 2004	IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE
IEC 62304:2006+AMD1:2015 CSV	MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
IEC 60068-2-47 : 3.0	ENVIRONMENTAL TESTING - PART 2-47: TESTS - MOUNTING OF SPECIMENS FOR VIBRATION, IMPACT AND SIMILAR DYNAMIC TESTS
ISO 8601 : 2004	DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
ISO 11137-2 : 2013(R2018)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
90/385/EEC : 1990 AMD 4 2007	COUNCIL DIRECTIVE OF 20 JUNE 1990 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES
ISO 10993-9 : 2009(R2013)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
ISO TS 10974 : 2012	ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE
ISO 14155 : 2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO 7000 : 2014	GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS
ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
EN 45502-2-1 : 2004	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT BRADYARRHYTHMIA (CARDIAC PACEMAKERS)
IEC 60068-2-14 : 6.0	ENVIRONMENTAL TESTING - PART 2-14: TESTS - TEST N: CHANGE OF TEMPERATURE
ISO 15223-1 : 2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
AAMI TIR42 : 2010	EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES
ISO 17665-1 : 2006(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

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ISO 14708-1 : 2014

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Standards Referenced By This Book - (Show below) - (Hide below)

Standards Referencing This Book - (Show below) - (Hide below)

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