The following 3 standards have been recently been updated, does anybody have a summary of what the changes were from the old version of the standard:

BS EN 1041:2008 Information supplied by the manufacturer of medical devices

BS EN 980:2008 Symbols for use in the labelling of medical devices

BS EN ISO 14630:2008 Non-active surgical implants. General requirements

Many thanks in Advance

I have reviewed BS EN 980:2008 Symbols for use in the labelling of medical devices.

The changes I have noted are:
(a) Clause 2 ‘Normative references’ contains 4 new standards.
(b) Clause 3 ‘Terms and definitions’ is new in EN 980: 2008. The definitions used have no impact on the daily use of symbols contained within this standard.
(c) Clause 4 ‘General requirements’ has a new sub-section regarding the proposal of symbols for adoption.
(d) Clause 5.1 ‘General’ includes a Note suggesting that even though the symbols in Clause 5 are already in use, you should consider explaining the meanings of these symbols on consumer medical devices.
(e) There are 10 new symbols in EN 980: 2008
- 5.20 “KEEP AWAY FROM SUNLIGHT”
- 5.21 “KEEP DRY”
- 5.22 “DO NOT RESTERILIZE”
- 5.23 “NON-STERILE”
- 5.24 “CONTROL”
- 5.25 “NEGATIVE CONTROL”
- 5.26 “POSITIVE CONTROL”
- 6.2 “CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX”
- 6.3 “DO NOT USE IF PACKAGE IS DAMAGED”
- 6.4 “STERILE FLUID PATH”
(f) There are no changed symbols in EN 980: 2008.
(g) There has been a meaning change for 1 symbol in EN 980: 2008. From "Caution, Consult Accompanying Documents" to "Caution".
(h) The symbol for “DATE OF MANUFACTURE” and “MANUFACTURER”
may be combined.

Hope this helps.