关于ISO 11607的理解

poo

各位老师，对劲在读ISO11607-1/2 2019，有些问题不太理解，希望可以得到解答
1、5.1.6 The following properties shall be evaluated:
b) biocompatibility and toxicological attributes;
NOTE This is usually restricted to material in contact with the device. Guidance on biocompatibility is given in ISO 10993-1. For further guidance, see ISO/TS 16775.
这里说的与医疗器械接触的产品要考虑的生物相容性，看ISO10993-1，
然后有说到：
4.3 The following shall be taken into account for their relevance to the overall biological evaluation of
the medical device:
c) packaging materials that directly or indirectly contact the medical device can transfer chemicals to
the medical device and then indirectly to the patient or clinician;
整体生物学评价的相关性，新增加了对于包装材料的考虑因素。
直接或间接接触医疗设备的包装材料可以将化学物质转移到医疗器械上，然后间接地影响病人或医生，
这里的生物相容性是只考虑化学物质就可以？


2、7 Usability evaluation for aseptic presentation
7.1 A documented usability evaluation shall be conducted to demonstrate that the sterile contents can be aseptically removed from the sterile barrier system for presentation.
7.2 The usability evaluation for aseptic presentation shall include an assessment of
a) the ability to identify where to begin opening,
b) the ability to recognize and perform the technique required to open the sterile barrier system without contaminating or damaging the contents, and
c) the ability to subsequently present the contents aseptically.
NOTE 1 It is best practice for this evaluation to consider conditions of use, including utilizing personal protective equipment as applicable (e.g. gloves and gowns).
NOTE 2 Sterile barrier systems require a presentation technique where contact of the presented sterile contents with the opened seal or closure is avoided to reduce the risk of contamination of the sterile contents by the external edge of the seal or closure which is not sterile.
NOTE 3 Sterile barrier systems require a presentation technique where exposure of presented sterile contents to potential contaminants (e.g. airborne particles, dust, etc.) is minimized.


这里提到的有文件记录验证拆器械的过程中是否会造成污染这一项大家有做过嘛？是否需要，我对这内容不太理解，是否可以这样理解？需要做这个验证吗？