BS ISO 8637-3:2024
体外血液净化系统 血浆过滤器

Extracorporeal systems for blood purification - Plasmafilters

BS ISO 8637-3:2024 发布历史

BS ISO 8637-3:2024由英国标准学会 GB-BSI 发布于 2024-06-30，并于 2024-06-30 实施。

BS ISO 8637-3:2024在国际标准分类中归属于: 11.040.40 外科植入物、假体和矫形。

BS ISO 8637-3:2024 体外血液净化系统 血浆过滤器的最新版本是哪一版？

最新版本是 BS ISO 8637-3:2024 。

BS ISO 8637-3:2024的历代版本如下：

• 2024年 BS ISO 8637-3:2024 体外血液净化系统 血浆过滤器
• 2018年 BS ISO 8637-3:2018 用于血液净化的体外系统 等离子体过滤器

1   Scope This document specifies requirements and test methods for plasmafilters , which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters , intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to; — extracorporeal blood circuits; — haemodialysers, haemodiafilters, haemofilters and haemoconcentrators; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems or equipment intended to perform plasma separation . NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637‑2. NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1.

标准号

BS ISO 8637-3:2024

发布

2024年

发布单位

英国标准学会

当前最新

BS ISO 8637-3:2024

 

 

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