Regulatory authorities recognize the critical nature of a sterile barrier system.In fact, they consider packaging an accessory or a component of the medical device, which implies that the package system is nearly as important as the device itself.The facts are, however, that this data is often incomplete or incorrect from the moment the data is captured.
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The English version of this specification is the only normative version. In particular, erratum [E09] relaxes the restrictions on element and attribute names, thereby providing in XML 1.0 the major end user benefit currently achievable only by using XML 1.1.
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