BS ISO 20417 pdf free download

BS ISO 20417-2021 pdf free download.Medical devices – Information to be supplied by the manufacturer.
a) Where necessary, a medical device or accessory shall be assigned a unique device identifier. NOTE This can be required by the authority having jurisdiction,
b) This identifier shall have a 1:1 relation to:
1) a single catalogue number;
2) a single model number; or
3) a single commercial product name.
Check conformance by inspection of the information supplied by the manufacturer.
5.11 Types of use/reuse
A unique use classification shall be assigned at the level of model number or catalogue number from one
of the following:
a) single use;
b) single patient multiple use; and
c) multiple patient multiple use.
Check conformance by inspection of the information supplied by the manufacturer.
5.12 Sterile
a) A medical device or accessory that is sterile shall be identified as sterile.
b) A sterile medical device or accessory shall be identified with the method of sterilization.
c) Medical devices or accessories available sterile and non-sterile shall have different:
1) model numbers; or
2) catalogue numbers.
Check conformance by inspection of the information supplied by the manufacturer.
6 Requirements for accompanying information
6.1 Requirements for information to be supplied on the label
6.1.1 Minimum requirements for the label
a) The information required in J. shall be provided as a label.
b) The information on the label shall be provided in a human-readable format.
c) The information required in J. shall be provided as a marking unless:
1) the size of the medical device or accessory does not allow fixation of this information on the medical device or accessory;
2) the nature of the outer surfaces does not allow fixation of this information on the medical device or accessory; or
3) the omission of these markings does not adversely affect the benefit/risk balance according to
ISO 14971:2019.
Check conformance by inspection of the label and, if appropriate, the marking or risk manaqement file.
6.1.2 Identification of the manufacturer
a) The label of a medical device or accessory shall include the name or trade name and, unless otherwise included In the IFU, the full address of
1) the manufacturer; and
2) where necessary, ii the manufacturer does not have an address within the locale, an authorized representative within the locale,
to which the responsible organization can refer.
NOTE Item 2) can be required by the authority having jurisdiction.
b) In locales where the manufacturer or their authorized representative is required to be registered,
the address used shall be the same as the registered address.
c) SymbollSo 7000-3082 or symbol5.1.1 from ISO 15223-1:- may be used to identify the manujàcturer.
d) Symbol 5.1.2 from ISO 15223-1:- may be used to identify the authorized representative.
1) When using symbol 5.1.2 from ISO 15223-1:-, the ‘EC may be replaced by the 2-letter or 3-letter country code given in ISO 3166-1.
2) The address of the authorized representative may be applied by someone other than manufacturer.
EXAM PIE A label applied by the authorized representative and not the manufacturer.
i) An additional label shall not obscure any information on the label provided by the manufacturer.BS ISO 20417 pdf download.