This standard specifies the general requirements for the production, labeling and handling of biological indicators and test bacterial suspensions intended for use in the validation and monitoring of sterilization cycles. This standard does not include the requirements for products that have been directly inoculated with test bacteria or the resuscitation procedures for such inoculated products, nor does this standard specify the requirements for biological indicators that use more than one strain or species of bacteria on a carrier.
GB 18281.1-2000 history
2015GB 18281.1-2015 Sterilization of health care products.Biological indicators.Part 1:General requirements
2000GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1: General