15/30328959 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
Hardcopy , PDF
English
30-09-2017
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 (normative) - 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
Annex E (informative) - Terminology - alphabetized index of
defined terms
Bibliography
BS ISO 16142-2.
| Committee |
CH/210
|
| DocumentType |
Draft
|
| Pages |
48
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
| ISO 7010:2011 | Graphical symbols — Safety colours and safety signs — Registered safety signs |
| 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) |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 19054:2005 | Rail systems for supporting medical equipment |
| 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/TS 19218-1:2011 | Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| ISO 690-2:1997 | Information and documentation — Bibliographic references — Part 2: Electronic documents or parts thereof |
| 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 3107:2011 | Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| 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 22612:2005 | Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration |
| 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 |
| ISO 22610:2006 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| 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 |
| ISO 23908:2011 | Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 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 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 |
| ISO 23907:2012 | Sharps injury protection — Requirements and test methods — Sharps containers |
| 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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