14/30290166 DC : 0
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
Available format(s)
Hardcopy , PDF
Language(s)
English
Publisher
Superseded date
31-03-2016
Superseded by
€22.71
Excluding VAT
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and performance
of medical devices
5 Use of standards and guides in support of the
essential principles
6 Essential principles and references to relevant
standards and guides
Annex A (informative) - Rationale and guidance
Annex B (normative) - Table relating essential principles
to standards
Annex C (informative) - Website listings of other standards
suitable for the medical device sector and for
assessment purposes
Annex D (informative) - Reference to the Essential Principles
by International Standards
Bibliography
BS ISO 16142-1
| Committee |
CH/210
|
| DocumentType |
Draft
|
| Pages |
50
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO/TS 13004:2013 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| ISO/TR 24971:2013 | Medical devices — Guidance on the application of ISO 14971 |
| ISO 14160:2011 | Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| IEC PAS 61910-1:2007 | Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy |
| ASTM F 2212 : 2011 : REDLINE | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| IEC 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 14937:2009 | 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 |
| ISO 25424:2009 | Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 7405:2008 | Dentistry — Evaluation of biocompatibility of medical devices used in dentistry |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| ISO/TS 19218-1:2011 | Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes |
| ISO 21969:2009 | High-pressure flexible connections for use with medical gas systems |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| ASTM F 2027 : 2016 : REDLINE | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO 9584:1993 | Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants |
| ISO 690-2:1997 | Information and documentation — Bibliographic references — Part 2: Electronic documents or parts thereof |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 18472:2006 | Sterilization of health care products — Biological and chemical indicators — Test equipment |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants — General requirements |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 9583:1993 | Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants |
| IEC 60580:2000 | Medical electrical equipment - Dose area product meters |
| ISO 20857:2010 | Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 15985:2014 | Plastics — Determination of the ultimate anaerobic biodegradation under high-solids anaerobic-digestion conditions — Method by analysis of released biogas |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 6474:1994 | Implants for surgery — Ceramic materials based on high purity alumina |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| ISO 7153-1:2016 | Surgical instruments — Materials — Part 1: Metals |
| IEC 60627:2013 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| ISO 14969:1999 | Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488 |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
| ISO 8828:2014 | Implants for surgery — Guidance on care and handling of orthopaedic implants |
| ISO 13402:1995 | Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| AAMI TIR49 : 2013 | DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS |
| ISO 13782:1996 | Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications |
| ISO 14161:2009 | Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| ISO 17664:2017 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 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 devices |
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