ISO 10993-12:2012
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 20
- Дата публикации:
- 29 июня 2012 г.
- Издание:
- ISO IS 10993 edition 4 version 1
- ICS:
- 11.100.20
ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following: test sample selection; selection of representative portions from a device; test sample preparation; experimental controls; selection of, and requirements for, reference materials; preparation of extracts. ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
Технические детали
- Технический комитет
- ISO/TC 194 - Biological and clinical evaluation of medical devices
- SKU
- ISO 10993-12:2012
Похожие стандарты
Другие стандарты ISO
ISO 8212:1986
ОтменёнSoaps and detergents — Techniques of sampling during manufacture
Overview Standard Reference: ISO 8212:1986 Title: Soaps and detergents - Techniques of sampling during manufacture ISO 8212:1986 defines standardized techniques for taking representative samples of s…
ISO 20662:2020
ДействующийShips and marine technology — Hopper dredger supervisory and control systems
Overview ISO 20662:2020 - Ships and marine technology: Hopper dredger supervisory and control systems (HD‑SCS) - specifies the components, structure, general requirements, and functional requirements…
ISO 3021:2023
ДействующийAdventure tourism — Hiking and trekking activities — Requirements and recommendations
Overview ISO 3021:2023 - Adventure tourism: Hiking and trekking activities - Requirements and recommendations defines safety-focused requirements and recommendations for hiking and trekking offered a…
ISO 3826-2:2008
ДействующийPlastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on l…
Overview ISO 3826-2:2008 - "Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets" defines a system of internatio…
ISO/IEC 24730-1:2014
ДействующийInformation technology — Real-time locating systems (RTLS) — Part 1: Application programming interface (API)
Overview ISO/IEC 24730-1:2014 specifies the Application Programming Interface (API) for Real‑Time Locating Systems (RTLS). The standard defines a minimal, interoperable boundary that lets application…
ISO 8668-5:1992
ДействующийAircraft — Terminal junction systems — Part 5: Detail specification for type 3 system
Overview - ISO 8668-5:1992 (Aircraft terminal junction systems, Type 3) ISO 8668-5:1992 defines the detail specification for Type 3 Terminal Junction Systems (TJS) used in aircraft electrical install…
ISO 7574-3:1985
ДействующийAcoustics — Statistical methods for determining and verifying stated noise emission values of machinery and e…
Overview ISO 7574-3:1985 is part of the ISO 7574 series on acoustics and provides a simple (transition) statistical method for determining and verifying stated noise emission values for batches (lots…
ISO 15638-15:2014
ДействующийIntelligent transport systems — Framework for cooperative telematics applications for regulated vehicles (TAR…
Overview - ISO 15638-15:2014 (Vehicle location monitoring, TARV) ISO 15638-15:2014 is part of the ISO 15638 suite for Intelligent Transport Systems (ITS) and defines the framework and data specificat…