hawo’s Future is Global - Adoption of the ISO 11607 Standard in Sydney -- MEDICA - World Forum for Medicine


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hawo’s Future is Global - Adoption of the ISO 11607 Standard in Sydney

From 18 – 22 April 2005, the standards committee of the ISO TC 198 WG 7 working group finally adopted the harmonisation of the European Standard EN 868-1 with the existing International Standard ISO 11607. The ISO 11607 standard will replace the first part of the European EN 868 series of standards. This guarantees a worldwide harmonisation of the packaging standards. The sections EN 8689 2-10 will remain in use. We have summarised the most important guidelines for you again:

The standard applies to every facility in which medical products are packaged and sterilised – including hospitals. All packaging processes must be validatable and reproducible, i.e. the process must always be the same. This applies to container packages and sheet material (Wrapping), as well as to heat sealable transparent packages sealed with a sealing machine. Non-validatable packaging systems, such as Self Seal Pouches, are no longer acceptable. The process is not reproducible and the risk of recontamination very high. The critical process parameters for any packaging system must be monitored and archived. The packaging system must be checked regularly using a suitable test. On account of the new standard, it is advisable only to buy or sell sealing devices in future which can monitor the sealing parameters. hawo offers a range of suitable sealing devices that will safely meet your future needs:

Impulse sealers:
- hm 460 / 660 V

Rotary sealers:
- hm 2020 DC
- hm 2010 DC
- hm 850 DC

The newly adopted ISO 11607 standard serves as a validation guide for packaging processes. The standard is expected to come into effect from the fourth quarter of 2005. The standard will then be available in the different national languages. The current draft (DIS) can already be purchased on
various national websites