 |
ISO 7740 Instruments for
surgery-scalpels with detachable blades-fitting dimensions |
|
BS 2982 Specifications for detachable
blades |
|
EN ISO 9001 Quality System-Specification
for Production and Installation |
|
ISO 14971 2000 Application of risk
management to medical devices. |
|
EU Council Directive 93/42/EEC for Medical Devices |
|
ISO 13485 Quality Systems - Medical
devices - Particular requirements for the application
of ISO 9001. |
|
BS 5194:Part I. Surgical Instruments-Specification
for stainless steel. |
|
BS427: Method for Vickers hardness
test and for verification of Vickers hardness testing
machines |
|
EN 552: Validation and routine control
of sterilization by irradiation. |
| |
|
