Standards used for the manufacture of Terragene´s products Numerical Reference Description Application ISO 13485 2016 Medical Devices Quality Management System Requirements for Regulatory Pusposes All.Medical Devices. Quality Management System. Requirements for Regulatory Pusposes. All Terragene®´s products Quality Management System. ISO 161421:2016 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices.
Trang 1Standards used for the manufacture of Terragene´s products
ISO 13485:2016
Medical Devices
Quality Management System
Requirements for Regulatory Pusposes
All Terragene®´s products - Quality Management System
ISO 16142-1:2016
Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
All Terragene®´s products
ISO 15223-1:2016
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1:
General requirements
All Terragene®´s products
ISO 11138-1:2017
IRAM 37102-1:1999
Sterilization of health care products
Biological indicators Part 1: General requirements
All Terragene® Bionova® Biological
Culture Media
ISO 11138-2:2017
IRAM 37102-2:1999
Sterilization of health care products
Biological indicators Part 2: Biological
sterilization processes
Terragene® Bionova® BT10, BT40, BT60, BT110, BTD40, BTD60, BTM40, BT110-IU Biological Indicators
ISO 11138-3:2017
IRAM 37102-3:1999
Sterilization of health care products
Biological indicators Part 3: Biological indicators for moist heat sterilization processes
Terragene® Bionova® BT20, BT50, BT60, BT21, BT22, BT23, BT24,
BT24S, BT202, BT220, BT221, BT222, BT223, BT224 Biological Indicators, Bionova® 1, 2,
PCD20-C, PCD220-1, PCD220-2, PCD220-PCD20-C,
Challenge Devices
ISO 11138-4:2017
Sterilization of health care products
Biological indicators Part 4: Biological indicators for dry heat sterilization processes
Terragene® Bionova® BT30, BT40, BT60, BTD40, BTD60, BTM40, BTM60 Biological Indicators,
ISO 11138-5:2017
Sterilization of health care products
Biological indicators Part 5: Biological indicators for low - temperature steam
processes
Terragene® Bionova® BT100 and BT102 Biological Indicators
Trang 2Numerical Reference Description Application
-
Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions
Attachment II: Examples of Validation
of Biological Indicator Incubation Time
Indicators
ISO 11140-1:2014
IRAM 37101-1:1999
Sterilization of health care products
Chemical indicators Part 1: General requirements
Indicators
ISO 11140-3:2007
Sterilization of health care products
Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Terragene Chemdye® BDA4 Chemical Indicator
ISO 11140-4:2007
Sterilization of health care products
Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection
of steam penetration
BD125X10/2, BD8948X, KBD8948X Chemical Indicators
ISO 11140-5:2007
Sterilization of health care products
Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
Chemical Indicators
Guidance for Industry and FDA Staff Premarket Notification [510(k)]
Submissions for Chemical Indicators
Terragene® Chemdye®, Cintape® and Integron® Chemical Indicators
EN 867-5:2001
Non-biological systems for use in sterilizers Specification for indicator
devices for use in performance testing for small sterilizers Type B and Type S
Terragene® Chemdye® Helix PCD
CDPCD2X15/P/M Helix Device
Test equipment
Cintape® and Chemink® Chemical Indicators
ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions
and tests
Terragene® Chemdye® PRO1 MICRO, KPRO2-E69 y KPRO2E-250 Cleaning Indicators – Hygiene Monitoring System
ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating
cleaning efficacy
CDWA4, CDWAH, CDWE, Lumenia Line
Trang 3Numerical Reference Description Application
HTM 01-01:2016
Health Technical Memorandum 01-01:
Management and decontamination of surgical instruments (medical devices)
Management and provision
Terragene® Chemdye® PRO1MICRO, KPRO2-E69 y KPRO2E-250 Cleaning Indicators – Hygiene Monitoring System
HTM 01-05:2013
Health Technical Memorandum 01-05:
Decontamination in primary care dental practices
Terragene® Chemdye® PRO1MICRO, KPRO2-E69 y KPRO2E-250 Cleaning Indicators – Hygiene Monitoring System
ANSI/AAMI
ST79:2017
Comprehensive guide to steam sterilization and sterility assurance
in health care facilities
Challenge Devices 1,
PCD20-2, PCD20-C, PCD220-1, PCD220-PCD20-2,
PCD222-C, PCD224-2, PCD224-C
Challenge Devices 1,
PCD26-2, PCD26-C