Item Brochure

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Product Quality Statement
Product Compliance
BD Vacutainer
®
Blood Collection Tubes and ancillary equipment are (non Annex II) In-Vitro Diagnostic Medical Devices. These comply with the require-
ments described in the European In Vitro Diagnostic Medical Device Directive 98/79/EC.
BD Hardpak
™
III Blood Collection Needles, BD Vacutainer
®
Blood Collection Sets, BD Safety-Lok
™
Blood Collection Sets, BD Microlance
™
Lancets and
Arterial Blood Gas Syringes with needles are (class IIa) Medical Devices and as such, comply with the requirements of the European Medical Device
Directive, 93/42/EEC.
All product unit labels ( and most packaging levels ) bear the CE mark, demonstrating conformity to the above Directives.
The UK manufacturing plant, which supplies most European product, is certificated to ISO 9000:2000, ISO 13485:2003 and ISO 14001:2003. As a
supplier to the US market the plant is also subject to FDA inspection and therefore holds an FDA establishment registration certificate. Copies of all
these certificates can be provided upon request.
Other BD manufacturing plants carry similar certification, which can also be provided upon request.
All products are designed and manufactured in accordance with the relevant international and or European standards. This includes but is not limited
to ISO 6710 ( for blood collection tubes ) ISO 6009 ( for blood collection needles ), EN 980 ( for symbols used on product labelling ).
The product shelf life is based on data from stability testing and varies according to specific products. All expiry dates are clearly printed on product
unit labels.
Clinical Data
Prior to launching a new product BD conducts extensive clinical testing and data can be provided upon request.
Whenever changing any manufacturer’s blood collection tube type, size, handling, processing or storage condition for a particular laboratory assay, the
laboratory personnel should review the tube manufacturer’s data to establish/verify the reference range for a specific instrument/reagent system. Based
on such information, the lab can then decide if a change is appropriate.
Product sterilisation
All products are sterilised using either gamma irradiation in accordance with ANSI/AAM/ISO 11137 - 1995 “Sterilisation of Health Care Products
(Requirements for Validation and Routine Control - Radiation Sterilisation)”, Ethylene Oxide (EtO) in accordance with ISO 11135 - 1994 “Validation and
Routine Control of Ethylene Oxide Sterilisation” or Moist Heat Sterilisation in accordance with EN554 : 1994 “Sterilisation of Medical Devices - Valida-
tion and Routine Control of Sterilisation by Moist Heat”. Microbiological environmental assessment for bio-burden levels is conducted regularly.
The sterilisation of BD Vacutainer
®
products is controlled by European Standards:
EN 550 : 1994 Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation
EN 552 : 1994 Sterilisation of medical devices - Validation and routine control of sterilisation by irradiation
EN 554 : 1994 Sterilisation of medical devices - Validation and routine control of sterilisation by moist heat
EN 556 : 1995 Requirement for terminally sterilised devices to be labelled “STERILE”
British Standards Institution
(BSI) - Certificate of Registration
- Compliance with ISO 13485 :
2003
BSI - Environmental
Management System -
Certificate of Registration-
Compliance with ISO 14001 : 2004
BSI - EC Certificate CE00362
(effective March 2004)
British Standards Institution
(BSI) - Certificate of
Registration - Compliance
with BS EN ISO 9001 : 2000