Surgical instruments -
Packaging, marking and instructions
1 Scope
This standard specifies the packaging, marking and instructions of surgical instruments.
This standard is applicable to ordinary packaging, disinfection packaging and aseptic packaging of surgical instruments.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding corrigendum), or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition applies.
GB 9969.1 General principles for preparation of instructions for use of industrial products
YY 0466 Medical devices - Symbols to be used with medical device labels labelling and information to be supplied (YY 0466-2003, ISO 15223:2000, IDT)
3 Packaging
3.1 Ordinary packaging
3.1.1 Products may be subjected to anti-rust or cleaning treatment before packaging, so as to ensure that the products are free from rust during the storage period.
3.1.2 For products with sharp ends or sharp edges, they shall be protected before packaging to prevent damage to them and their packagings.
3.1.3 The type of packaging shall ensure the products will be not affected during normal storage and transport.
3.1.4 The primary packaging may be single packaging or packaging by instrument set.
