BS ISO 16142-1:2016
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical devices. Recognized essential principles of safety and performance of medical devices 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
Withdrawn date
07-03-2024
Language(s)
English
Published date
03-31-2016
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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
Annex E (informative) - Terminology - alphabetized index
of defined terms
Bibliography
Gives significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended.
| Committee |
CH/210
|
| DevelopmentNote |
Supersedes BS PD ISO/TR 16142 & 14/30290166 DC. (03/2016)
|
| DocumentType |
Standard
|
| Pages |
60
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
This part of ISO16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This part of ISO16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).
This part of ISO16142 also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to medical devices other than IVD medical devices. Future ISO16142-2 is intended to identify and describe the essential principles of safety and performance, which need to be considered during the design and manufacturing process of IVD medical devices.
NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others.
This part of ISO16142 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.
| Standards | Relationship |
| ISO 16142-1:2016 | Identical |
| 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 |
| ISO 14408:2016 | Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information |
| ISO 9168:2009 | Dentistry Hose connectors for air driven dental handpieces |
| IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| IEC 61168:1993 | Radiotherapy simulators - Functional performance characteristics |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| ISO 5364:2016 | Anaesthetic and respiratory equipment — Oropharyngeal airways |
| IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| ISO 5360:2016 | Anaesthetic vaporizers Agent-specific filling systems |
| ISO 8827:1988 | Implants for surgery Staples with parallel legs for orthopaedic use General requirements |
| ISO 690:2010 | Information and documentation Guidelines for bibliographic references and citations to information resources |
| ISO 7376:2009 | Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation |
| ISO 21649:2006 | Needle-free injectors for medical use — Requirements and test methods |
| 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 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| IEC 60731:2011+AMD1:2016 CSV | Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| ISO 11663:2014 | Quality of dialysis fluid for haemodialysis and related therapies |
| ISO 21534:2007 | Non-active surgical implants Joint replacement implants Particular requirements |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| ISO 22523:2006 | External limb prostheses and external orthoses — Requirements and test methods |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| IEC 61674:2012 | Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| IEC TR 62266:2002 | Medical electrical equipment - Guidelines for implementation of DICOM in radiotherapy |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 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 61689:2013 | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| IEC 61846:1998 | Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
| ISO 8637:2010 | Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ISO 23747:2015 | Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
| 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 8638:2010 | Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 19054:2005 | Rail systems for supporting medical equipment |
| ISO 9713:2002 | Neurosurgical implants Self-closing intracranial aneurysm clips |
| IEC 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
| 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 |
| IEC 60976:2007 | Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| IEC 61847:1998 | Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics |
| ISO 8835-7:2011 | Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| 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 13958:2014 | Concentrates for haemodialysis and related therapies |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ISO 18777:2005 | Transportable liquid oxygen systems for medical use — Particular requirements |
| ISO 21536:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
| 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 |
| IEC 62083:2009 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning 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 |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO 14457:2017 | Dentistry — Handpieces and motors |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| ISO 9584:1993 | Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants |
| IEC 62563-1:2009+AMD1:2016 CSV | Medical electrical equipment - Medical image display systems - Part1: Evaluation methods |
| 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 |
| ISO 5362:2006 | Anaesthetic reservoir bags |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 18778:2005 | Respiratory equipment — Infant monitors — Particular requirements |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 14602:2010 | Non-active surgical implants — Implants for osteosynthesis — Particular requirements |
| ISO 6474-1:2010 | Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 11197:2016 | Medical supply units |
| ISO 3107:2011 | Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements |
| 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 7199:2016 | Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
| 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 26722:2014 | Water treatment equipment for haemodialysis applications and related therapies |
| 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 |
| 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 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| 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 60118-15:2012 | Electroacoustics - Hearing aids - Part 15: Methods for characterising signal processing in hearing aids with a speech-like signal |
| ISO 23500:2014 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies |
| ISO 27186:2010 | Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| IEC 61223-3-4:2000 | Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment |
| ISO 13959:2014 | Water for haemodialysis and related therapies |
| IEC 61223-2-6:2006 | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests imaging performance of computed tomography X-ray equipment |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| ISO 7153-1:2016 | Surgical instruments Materials Part 1: Metals |
| ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
| IEC 60627:2013 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| ISO 14879-1:2000 | Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays |
| 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 |
| IEC 61676:2002+AMD1:2008 CSV | Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology |
| 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 7197:2006 | Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components |
| IEC 62494-1:2008 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| IEC 61303:1994 | Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance |
| AAMI TIR49 : 2013 | DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS |
| IEC 62359:2010+AMD1:2017 CSV | Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| 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 |
| IEC TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples |
| 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 14607:2007 | Non-active surgical implants Mammary implants Particular requirements |
| ISO 22675:2016 | Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 11318:2002 | Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements |
| ISO 21535:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants |
| 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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