There are two documents which outline all of the requirements for NSF Certification of Biosafety Cabinetry. They include NSF/ANSI Standard 49 and the NSF Certification Policies for Biosafety Cabinetry.
The NSF Standard defines the specific requirements to which a product must conform, such as those relating to materials, design, construction, product literature, performance criteria, test methodologies, and quality control.
The policies include both general requirements, applicable to all of the NSF Certification programs, and program specific requirements, applicable only to the NSF biosafety cabinetry certification program.
General Program Policies (examples):
- Marking of the certified product and proper use of manufacturer's model designation.
- Annual audits, as performed at the manufacturer's facility. Audits are conducted by NSF representatives to assess that the product being manufactured continues to comply with all of the specifications which define the certified product.
- Corrective action steps to be taken by the manufacturer in the event certified product is found to be no longer in compliance with the requirements of certification.
- Enforcement actions taken by NSF for general noncompliance with the requirements for certification.
- Administrative review provisions, as requested by any party directly affected by a decision or action of NSF regarding the certification of a product.
- Appeals process, as requested by any party directly affected by a decision or action of NSF resulting from an administrative review.
- Complaints process in the event NSF receives complaints relating to certified products, or misuse of the NSF Mark by a certified or non-certified company.
- Advertising requirements for proper use of the NSF Mark on sales literature, technical publications, promotional materials, packaging, catalogs, et cetera.
- Records maintenance for those relating to certified product, including purchased materials, production, shipment, and inventory.
- Confidentiality provisions for the non-disclosure of any confidential information supplied to NSF by the company regarding the product, including formulations, components, processes, ingredients, or the identity of the company's suppliers and distributors.
Program Specific Policies (examples):
- Listing Book information for all certified products, including such things as company name, telephone number, and address, product description, trademark/model designation, inflow and downflow operating velocities, acceptable options, et cetera. Listing books for certified biosafety cabinets and accredited field certifiers are published once per year.
- Periodic Testing of products at five year intervals.
- Quality Control testing by the manufacturer on all cabinets produced.
The policy book also includes copies of the program application form and contract for certification services.
The policies are developed by the program office, in coordination with members of the stakeholder community. They are then reviewed and balloted by a consensus body, with representatives from the industry, regulatory community, and users, collectively termed the NSF Certification Council.
