ISO 14607:2018
Non-active surgical implants — Mammary implants — Particular requirements
Non-active surgical implants — Mammary implants — Particular requirements
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 41
- Дата публикации:
- 13 апреля 2018 г.
- Издание:
- ISO IS 14607 edition 3 version 1
- ICS:
- 11.040.40
ISO 14607:2018 specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
Abstract
Overview
ISO 14607:2018 - "Non-active surgical implants - Mammary implants - Particular requirements" is a level‑2 ISO standard that specifies safety‑related requirements specific to mammary (breast) implants. It complements the general requirements for non‑active surgical implants by defining detailed expectations for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and the information manufacturers must supply.
Похожие стандарты
Стандарты, упомянутые в описании