BS 13/30278952 DC

Cross References:
CEN/TR 15592
ISO 9004:2000
CEN/TS 15277
EN 207
EN 285
EN 455-1
EN 455-2
EN 455-3
EN 455-4
EN 794-3
EN 1040
EN 1041
EN 1422
EN 1500
EN 1644-1
EN 1644-2
EN 12470
EN 13060
EN 13795
EN 14180
EN 15224
ISO 9001:2008
EN 15986
EN 60601-2-4
IEC 60601-2-4:2010
EN 60601-2-25
IEC 60601-2-25:1993/AMD1:1999
EN 60601-2-26
IEC 60601-2-26:2002
EN 60601-2-27
IEC 60601-2-27:2005
EN 60601-2-30
IEC 60601-2-30:1999
EN 60601-2-34
IEC 60601-2-34:2000
EN 60601-2-41
IEC 60601-2-41:2009
EN 60601-2-46
IEC 60601-2-46:2010
EN 60601-2-47
IEC 60601-2-47:2001
EN 60601-2-52
IEC 60601-2-52:2009
EN 60601-2-57:2011
IEC 60601-2-57:2011
EN 80601-2-12
ISO/IEC 80601-2-12:2011/CORR:2011
EN 80601-2-55
ISO 80601-2-55:2011
EN ISO 1942
ISO 1942:2009
EN ISO 6009
ISO 6009:1992
EN ISO 7396
EN ISO 8362-6
ISO 8362-6:2010
EN ISO 8362-7
ISO 8362-7:2006
EN ISO 9000
ISO 9000:2005
EN ISO 9170-2
ISO 9170-2:2008
EN ISO 10079
EN ISO 10781
ISO 10781:2009
EN ISO 11073
EN ISO 11135-1
ISO 11135-1:2007
EN ISO 11810-1
ISO 11810-1:2005
EN ISO 11810-2
ISO 11810-2:2007
EN ISO 12967
EN ISO 13485
ISO 13485:2003
EN ISO 13606
EN ISO 14607
ISO 14607:2007
EN ISO 14630
ISO 14630:2012
EN ISO 14644-1
ISO 14644-1:1999
EN ISO 14971
ISO 14971:2007
EN ISO 15223-1
ISO 15223-1:2012
EN ISO 15225
ISO 15225:2010
EN ISO 16054
ISO 16054:2000
EN ISO 16061
ISO 16061:2008
EN ISO 17665-1
ISO 17665-1:2006
EN ISO 18812
ISO 18812:2003
EN ISO 21090
ISO 21090:2011
EN ISO 25424
ISO 25424:2009
EN ISO 27789
ISO/FDIS 27789:2012
EN ISO 27799
ISO 27799:2008
EN ISO 80601-2-61
ISO 80601-2-61:2011
ISO 10001
ISO 10002
ISO 10003
ISO/TR 12773
ISO 17090
ISO 18308
ISO 19011
ISO/TS 21547
ISO/TR 21548
ISO/TS 22600
ISO 26000
ISO 31000
ISO 80601-2-13
IEC/TR 60825-8
Directive 96/29
Directive 97/43
Directive 84/466
Directive 2001/83/EC
Directive 2005/36/EC
Directive 2006/25/EC


All current amendments available at time of purchase are included with the purchase of this document.



Keywords: Medical equipment; Implants (surgical); Medical instruments; Technical documents; Instructions for use; Handbooks; Documents; Marking; Identification methods; Packaging; Sterile equipment; Definitions; Consumer-supplier relations; Symbols; Safety measures ; Hazards

Product Code(s): 30278952,30278952

This product references:ISO 1942:2009 - Dentistry - Vocabulary
ISO 80601-2-61:2011 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 11810-2:2007 - Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition
ISO 14971:2007 - Medical devices - Application of risk management to 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
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 27799:2008 - Health informatics - Information security management in health using ISO/IEC 27002
ISO 9004:2000 - Quality management systems -- Guidelines for performance improvements
ISO 9001:2008 - Quality management systems -- Requirements
BS EN 60601-2-57:2011 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
ISO 80601-2-55:2011 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 6009:1992 - Hypodermic needles for single use - Colour coding for identification
ISO 8362-6:2010 - Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials
ISO 8362-7:2006 - Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary
ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11810-1:2005 - Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration
ISO 14607:2007 - Non-active surgical implants - Mammary implants - Particular requirements
ISO 14630:2012 - Non-active surgical implants - General requirements
ISO 14644-1:1999 - Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness
ISO 15223-1:2012 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15225:2010 - Medical devices - Quality management - Medical device nomenclature data structure
ISO 16054:2000 - Implants for surgery -- Minimum data sets for surgical implants
ISO 16061:2008 - Instrumentation for use in association with non-active surgical implants - General requirements
ISO 18812:2003 - Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
ISO 21090:2011 - Health informatics - Harmonized data types for information interchange
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 9170-2:2008 - Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems