Standards Download Free
BS pdf,ASME pdf,ISO pdf,ASTM pdf,AS pdf,GB pdf
Biological evaluation of medical devices
  • ISO 10993-12-2021 pdf free.Biological evaluation of medical devices 一 Part 12: Sample preparation and reference material ls. 5 Designation 5.1 General An infusion glass bottle for medical use compiying witfl me requirements laid aown in tnis part of ISO 8536 is designated using the descriptor infusion bottle followed by, in the order given, a reference to this part of Iso 8536, the model of the infusion bottle, the nominal capacity, the colour and the hydrolytic resistance container dass (see 8.1). EXAMPLE 1 An infusion bottle (model A) with a nominal capacity of 500 ml. made of colourless glass (Cl) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows: Infusion bottle ISO 8536-1 — A — 500 — cI — HC 2 EXAMPLE 2 An infusion bottle (model C) with a nominal capadty of 500 ml, made of colourless glass (ci) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows: Infusion bottle ISO 8536-1 — C — 500 — cI — HC 2 5.2 Location of designation marks The designation marks on the…