|
ISO 4871:1996
|
Acoustics — Declaration and verification of noise emission values of machinery and equipment |
|
ISO 3744:2010
|
Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
|
DIN EN 61672-1:2014-07
|
ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013) |
|
DIN EN 60601-1-1 : 2002
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
|
IEC 60601-1:2005+AMD1:2012 CSV
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
|
DIN EN ISO 17664:2016-06 (Draft)
|
PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
|
ISO 17510-1:2007
|
Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
|
ISO 5356-1:2015
|
Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
|
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 |
|
DIN EN ISO 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
|
DIN EN ISO 3744:2011-02
|
Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010) |
|
ISO 5356-2:2012
|
Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
|
ISO/TR 16142:2006
|
Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
|
ISO 23328-2:2002
|
Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
|
DIN EN ISO 5356-1:2015-06
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015) |
|
AAMI TIR 12 : 2010
|
DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
|
ISO 23328-1:2003
|
Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance |
|
DIN EN ISO 5356-2:2013-03
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS (ISO 5356-2:2012) |
|
VDE 0750-1-1 : 2002
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY; 1 COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
|
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 |
|
VDE 0750-1 : 2013
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
|
IEC 60601-1-1:2000
|
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
|
DIN EN ISO 17510-1:2009-07
|
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
|
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
|
DIN EN ISO 4135:2002-03
|
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001 |