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BS ISO 16142-1:2016

Current
Current

The latest, up-to-date edition.

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

Language(s)

English

Published date

03-31-2016

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.

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.

Committee
CH/210
DevelopmentNote
Supersedes BS PD ISO/TR 16142 & 14/30290166 DC. (03/2016)
DocumentType
Standard
Pages
60
PublisherName
British Standards Institution
Status
Current
Supersedes

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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