Dress Code in ISO Class 8 - Plastic Parts for Medical Devices

[Ajit Basrur]

Hi,

We have an ISO Class 8 for manufacturing plastic parts for medical devices. For cleanroom entry, we have coats, overcaps, beardcovers and haircovers.

Apart from these basic things, is there any restriction esp. for ladies not to wear skirts etc ?

 

[Jen Kirley]

Re: Dress Code in ISO Class 8

Restrictions are established based on risk aren't they? If I understand this right a Class 8 controls at the >= 0,5 µm per cubic meter of air contamination rate.

What means did your group use to arrive at its present requirements? FMEA? HACCP? These same procedures can be revisited to address additional questions such as the one about skirts as they arise.

What ISO standard are you registered to? Did you use ISO 14644 series? I understand ISO 14644-4 and 14644-5 cover clean room deign and operation, respectively.

This site offers resources that are specific to clean room needs. http://www.s2c2.co.uk/merchandise/#iso I am not affiliated with the site or its included references. Since I don't know anything about your present requirement design procedure, I regretfully can't reliably tell you that skirts should be allowed.

If it's an opinion you want, I'd say no skirts as the chances for particulate introduction in skirts, especially loose and flowing fabric, is greater than that of slacks. Second problem is the exposed skin, which gives off contaminating particulates through ex-foliation.

 

[Ajit Basrur]

Re: Dress Code in ISO Class 8

We have only ISO 13485 certification.

Despite ladies wearing skirts, we are able to meet the particulate level for ISO Class 8 ie all the particulates are well within the acceptance criteria. However was wondering, if we continue with the practise, can anyone give a non conformance as the skin is exposed or not complying to the ideal dress code ?

 

[Jen Kirley]

If skirts are found to be within compliance according to the standard, procedures and tests you have conducted, I see no reason why worry about a nonconformance.

My understanding is that ISO doesn't dictate details like attire, even for clean rooms. It dictates that organizations define levels of control, how to meet them, show adequate compliance/ follows the plan, etc.

Anyone out there with differing input?