Standards

Quality Management System standards applied by our company;

TS EN ISO 9001: 2016 Quality Management System
TS EN ISO 13485: 2015 Quality Management System for Medical Devices
Medical Device Directive 93/42/ EEC
In-Vitro Medical Device Directive 98/79/EEC
TS ISO 45001:2018 Occupational Health and Safety Systems - Requirements and user guide

Quality control standards we follow for our medical device disinfectants and biocidal products are:

Standard No	Standard Name
TSE EN 1040	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
TSE EN 1275	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
EN 1276	Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas - Test method and requirements (phase 2, step 1)
EN 1500	Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)
EN 1650	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas - Test method and requirements (phase 2, step 1
EN 12791 +A1	Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
EN 13624	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area – Test method and requirements (phase 2, step 1)
EN 13704	Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic, and institutional areas - Test method and requirements (phase 2, step 1)
EN 13727+ A2	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
EN 14347	Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1, step 1)
EN 14348	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
EN 14476 + A2	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
EN 14561	Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
EN 14562	Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
EN 14563	Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)
AOAC	Sporicidal efficacy test method (phase 2, step 2)

The general inclusive standards that are followed in our production and quality control laboratories for all products in our "Microbiology Culture Media" product group are as follows:

Standard No	Standard Name
M22-A3	Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard – Third Edition
TS EN ISO 11133	Microbiology of food, animal feed and water - Preparation, production, storage, and performance testing of culture media
TS EN ISO 22716	Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices
TS EN ISO/IEC 17025:2017	General requirements for the competence of testing and calibration laboratories

The product-specific standards that are applied in our production and quality control laboratories for microbiology culture media for public health laboratories are as follow:

Standard No	Standard Name
TS EN ISO 6222	Water quality- Enumeration of culturable microorganisms- Colony counting by inoculation in a nutrient agar culture medium.
TS EN ISO 6887-1	Microbiology of the food chain - Preparation of test samples, initial suspension, and decimal dilutions for microbiological examination - Part 1: General rules for the preparation of the initial suspension and decimal dilutions (ISO 6887-1:2017)
TS EN ISO 6887-4	Microbiology of the food chain - Preparation of test samples, initial suspension, and decimal dilutions for microbiological examination - Part 4: Specific rules for the preparation of miscellaneous products (ISO 6887-4:2017)
TS EN ISO 6887-5	Microbiology of the food chain — Preparation of test samples, initial suspension, and decimal dilutions for microbiological examination — Part 5: Specific rules for the preparation of milk and milk products
TS EN ISO 7899-1	Water quality - Detection and enumeration of intestinal enterococci in surface and wastewater - Part 1: Miniaturized method (most probable number) by inoculation in liquid medium (ISO 7899-1:1998)
TS EN ISO 7899-2	Water quality - Detection and enumeration of intestinal enterococci - Part 2: Membrane filtration method
TS EN ISO 8199	Water quality - General requirements and guidance for microbiological examinations by culture
TS 8019 EN 26461-1	Water Quality-Detection and Enumeration of the spores of sulfite-Reducing Anaerobes (Clostridia)-Part: 1 Method by enrichment in a liquid medium
TS 8020 EN 26461-2	Water quality- Detection and enumeration of the spores of the sulfite-reducing anaerobes (clostridia)-Part 2: Method.
TS EN ISO 9308-1	Water quality - Enumeration of Escherichia coli and coliform bacteria - Part 1: Membrane filtration method for waters with low bacterial background flora
TS EN ISO 9308-2	Water quality - Enumeration of Escherichia coli and coliform bacteria - Part 2: Most probable number method
TS EN ISO 9308-3	Water quality- Detection and enumeration of Escherichia coli and coliform bacteria in surface wastewater- Part 3: Miniaturized method (most probable number) by inoculation in liquid medium
TS EN ISO 16266	Water quality - Detection and enumeration of Pseudomonas aeruginosa - Method by membrane filtration
TS EN ISO 17516	Cosmetics - Microbiology - Microbiological limits (ISO 17516:2014)
TS EN ISO 18415	Cosmetics - Microbiology - Detection of specified and non-specified microorganisms
TS EN ISO 19458	Water quality - Sampling for microbiological analysis
TS EN ISO 21149	Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria

Standards

since 1990 Gül Biyoloji Laboratuvarı

since 1990
Gül Biyoloji Laboratuvarı