CLEANROOM COMPLIANCE RESOURCES
Ensuring your Cleanroom meets the Highest Standards
Clarity in a Complex
Regulatory Environment
Cleanroom compliance is driven by a network of global standards, regulatory agencies, and industry guidelines, each with its own requirements and implications. Understanding how they apply to your facility is critical to maintaining performance, passing inspections, and avoiding costly disruptions.
At 603 Testing & Certification, we don’t just test, we help you meet and navigate these standards with confidence. From ISO classifications to FDA, IEST, and NSF requirements, our team ensures your cleanroom is operating exactly as it should.
Below is a breakdown of the key organizations and standards that define equipment compliance and how they impact your operation.
Understanding Cleanroom Standards
ISO is the world’s largest developer and publisher of International Standards. ISO is a network of the national standards institutes of 159 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products the emit radiation.
IEST is an international, technical society of engineers, scientists, and educators that serves its members and the industries they represent (simulating, testing, controlling, and teaching the environments of earth and space) through education and the development of recommended practices and standards.
The Institute oversees the creation, promulgation, and use of thousands of norms and guidelines that directly impact businesses in nearly every sector.
NSF International, an independent, nonprofit, nongovernmental organization and the developer of the NSF 49 standard, is dedicated to being the leading global provider of public health and safety based risk management solutions while serving the interests of all stakeholders.
USP is a non-governmental, official public standards-setting authority for prescription and over-the-counter medicines and other healthcare products manufactured or sold in the United States.
The European Commission represents the general interest of the EU and is the driving force in proposing legislation (to Parliament and the Council), administering and implementing ED policies, enforcing EU law (jointly with the Court of Justice) and negotiating in the international arena.
