USER MANUAL (Instruction for Use) SW 2.9
Reference to Standards
Version 2.9.7 dated 2020-12-23 Page 67 of 75
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11 REFERENCE TO STANDARDS
Standards Content
MPG German Medical Device Law
93/42/EWG EU Medical Device Directive
EN14971 Medical devices - Application of risk management to medical devices
EN60 601-1 Medical electrical equipment - Part 1: General requirements for safety
EN60 601-1-2 Medical electrical equipment – Part 1: General requirements for safety; 2.
collateral standard: Electromagnetic compatibility; requirements and tests
EN60 601-1-4 Medical electrical equipment – Part 1: General requirements for safety; 4.
collateral standard: Programmable electrical medical systems
EN60529 Degrees of protection provided by enclosures (IP code)
EN61558 Safety of transformers
ISO 7000 Graphical Symbols for use on equipment
EN540 Clinical investigation of medical devices for human subjects
EN1707 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other
medical equipment - Lock fittings; German version EN 1707:1996
EN1041 Information supplied by the manufacturer with medical devices; German version
EN 1041:1998
EN 11137-1
Sterilization of medical devices - Validation and routine control of sterilization by
irradiation
EN 11137-2
Sterilization of health care products - Radiation - Part 2: Establishing the
sterilization dose
EN 11607-1
Packaging for terminally sterilized medical devices - Part 1: Requirements for
materials, sterile barrier systems and packaging systems
EN 11607-2
Packaging for terminally sterilized medical devices - Part 2: Validation
requirements for forming, sealing and assembly processes
EN 17665-1
Sterilization of medical devices - Validation and routine control of sterilization by
moist heat
EN 50272-2-4 Safety requirements for battery and installation
ISO 17664 Sterilization of medical devices - Information to be provided by the manufacturer
for the processing of resterilizable medical devices
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
UL 2601-1 Medical electrical equipment
SFDA Regulations of Medical Device according to the Chinese State Food and Drug
Administration (SFDA)
FDA Regulations for Medical Device according to the United States Food and Drug
Administration (FDA)
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems:
DC3 – Single package without pallet or skid, LTL motor freight; including D4332
(climate conditioning), D5276 (drop test), D642 (vehicle stacking), D4728 (vehicle
vibration [truck and air]), D999 A1 (loose-load vibration)
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