Industry Standards

As a trusted name in labs, universities, hospitals and manufacturing facilities across the globe, Beckman Coulter Life Sciences is committed to helping our customers maintain compliance with standards established by all applicable governments and agencies.


USP <1046> Standards for Cell and Tissue-Based Products
EU IVD-Regulation (IVDR) IVDR is a marathon, not a sprint. We will help you go the distance.
USP <643> Represents the general method for measuring total organic carbon (TOC) in water used for pharmaceutical applications
EU GMP Annex 1 Guidance for the manufacturing of sterile medicinal products
$laser-diffraction-particle-2017-05$ ISO 21501 For determination of particle size distribution for single-particle light-interaction methods
USP <788>, <787> and EP2.9.19 Defining allowable limits of sub-visible particulates in parenteral formulations
ICH Q2 Is an expert working group with representation from the United States, European and Japanese Pharmacopoeias.
USP <787> Particle counting analysis techniques for measuring contamination and specifying limits
ISO 14644 Cleanliness in cleanrooms and clean zones, addressing specifications and rules for certification
21 CFR Part 11 Mandates the conditions under which electronic records must be generated and defended
ALCOA ALCOA defines good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate.
ISO Regulations The Switzerland-based International Organization for Standard (ISO) is a non-governmental, independent consortium of 165 member countries working toward a common set of goals.
ISO 11171 Liquid particle counting calibration and performance guidelines for acceptable operation
EP 2.2.44 Chapter 2.2.44 of the European Pharmacopoeia describes the procedures used to qualify a chosen method for analyzing total organic carbon (TOC)—and the interpretation of results in limit tests.
USP <790> Guidance on visible particulates in products intended for parenteral administration