ANSI AAMI ISO 13488-1996 pdf download
ANSI AAMI ISO 13488-1996 pdf download.Quality systems – Medical devices – Particular requirements for the application of ISO 9002
1 Scope
This International Standard specifies, in conjunction with ISO 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices. This International Standard, in conjunction with ISO 9002, is applicable when there is a need to assess a medical device supplier’s quality system. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this International Standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention. NOTE- -In this International Standard the term“If appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be“appropriate” unless the supplier can document a justification otherwise. A requirement is considered“appropriate” if its non-implementation could result in the product not meeting its specified requirements, and/or the supplier being unable to carry out corrective action.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision，and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 8402:1994, Quality management and quality assurance- -Vocabulary. ISo 9002:1994, Quality systems- -Model for quality assurance in production, installation and servicing. ISO 11137:1995, Sterilization of healthcare products- Requirements for validation and routine control- -Radiation sterilization.
3.2 active medical device: Any medical device (see 3.1) relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.
3.3 active implantable medical device: Any active medical device (see 3.1 and 3.2) which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
3.4 implantable medical device: Any medical device (see 3.1) intended
– to be totally or partially introduced into the human body or a natural orifice, or
– to replace an epithelial surface or the surface of the eye,
by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and which can only be removed by medical or surgical intervention.
NOTE- This dfinition applies to implantable medical devices other than active implantable medical devices.
3.5 sterile medical device: Any medical device labeled as sterile. (See 3.6.1 of ISO 11137:1995.)
NOTE-Requirements for labeling a medical device as sterile may be subject to national or regional regulations or standards.
3.6 labeling: Written, printed or graphic matter
一affixed to a medical device or any of its containers or wrappers, or
accompanying a medical device,related to identification, technical description, and use of the medical device, but excluding shipping documents.
NOTE- For the purposes of this International Standard the term “marking” as used in ISO 9002 is interpreted to mean “labeling”.
3.7 customer complaint: Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device (see 3.1) that has been placed on the market.
