Is environmental extremes testing now a requirement of ISO 11607-01?
It is not accurate to say that environmental extremes testing is a requirement; however, the standard indicates in several areas that the package design shall consider the effects of distribution, storage and handling. Environmental extremes should be considered a distribution and/or storage effect. The sections that imply that these environmental extremes shall be considered include: 6.2.3 (h) 6.2.3 (j) 6.3.4 6.4.4 (Note) It should also be pointed out that this requirement is not a new provision of the standard, but is only being restated in this Part and is being given more emphasis than in previous editions of the standard. In order to comply with this provision, as stated in section 6.3.4, you must produce packages specifically for the performance evaluation (final package validation), as opposed to taking packages from a normal production lot for the validation testing. So, a specific manufacturing ‘run’ or ‘shift’ should be conducted with the machine set-up at the settings that p
