BS ISO 19611:2017

Действует

Traditional Chinese medicine. Air extraction cupping device — 18 стр.

Ссылочные документы

Действует

Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

Заменен

Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices — 26 стр.

Действует

Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 36 стр.

Заменен

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.

Действует

Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.

Действует

Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.

Действует

Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.

Действует

Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 стр.

Действует

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements — 32 стр.