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13/30260084 DC : 0

NA
NA

Status of Standard is Unknown

BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
Available format(s)

Hardcopy , PDF

Language(s)

English

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Respiratory therapy tubing connectors
7 Respiratory therapy tubing
8 Marking
9 Packaging
Annex A (informative) - Rationale
Annex B (informative) - Hazard identification for
        risk assessment
Annex ZA (informative) - Relationship between this
         document and the Essential Requirements of
         EU Directive 93/42/EEC
Bibliography

BS ISO 17256

Committee
CH/121/5
DocumentType
Draft
Pages
17
PublisherName
British Standards Institution
Status
NA

ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
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 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 27427:2013 Anaesthetic and respiratory equipment — Nebulizing systems and components

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