SQM Appendix P
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Issue A
Product Marking- Medical Devices
All products supplied to HoMedics Group Ltd must be marked with all the appropriate marking to satisfy all relevant legislative and HGL in-house requirements. The following is a list of what should be on the product or packaging. These are standard requirements – please remember that the requirements for each individual product will be included in the Product Specification which is issued for each product.
Batch Code-to be included on all products, gift boxes and outer cartons
YYYY MM
is the layout of the Batch Code, where YYYY is the year of production and MM is the month of production.
CE Mark -The CE Mark must be on all medical devices, for class 1 medical devices just the CE mark is required. For class I metrology/sterile, Class IIa, Class IIb and Class III, on HoMedics branded products this must state our notified bodies identification number below the CE mark, which is currently 0120, as illustrated below.
The CE Mark shall be on the product, gift box and IB
correct font to beused.
The CE mark must be a min of 5mm high
0120
WEEE Mark-HGL shall confirm when this mark is to be used
When requested shall be on product, gift box and IB
correct style to be used
min height 7mm
Battery Mark-to be on all batteries except for coin type
When coin cell batteries are supplied to be on IB and Giftbox
correct style to be used
min height 7mm
Class II products-all mains powered products that are designed to Class II spec
Rating label-all correct technical information to be included on the rating label
Label to be approved by HGL prior to use
Label to be printed, moulded or sewn into the product as appropriate
“rub test” to be done on all printing – ref to BS EN 60335-1:2002 + A2:2006 para 7.14
Information to be in agreement with appropriate test reports
HGL full address is also to be stated on the rating label, not the
PO Box address.
Consult the IB - This symbol is to be applied to the product,
to advise the user to consult the operating instructions.
Use by date -Where applicable the use by date must
be stated in this format, where the first
four digits are the year and the last 2 are
the month.
The type symbol for the degree of protection against electrical shock, must be on both the product and packaging, where required.
B Equipment providing a particular degree of protection against electric shock, particularly regarding allowable leakage currents and reliability of the protective earth connection (if present).
BF As type B but with isolated or floating (F - type) applied part or parts.
CF Equipment providing a higher degree of protection against electric shock than
type BF, particularly with regard to allowable leakage currents, and having floating applied parts.
Environmental - The product shall remain operational in NORMAL USE within its
specification after transport or storage in the following environmental
temperature range:
-25°C without relative humidity control; and
+70°Cat a relative humidity up to 93%, non-condensing;
After having been removed from its protective packaging and
subsequently between uses.
If the instructions for use state a more restricted range of environmental
transport and storage conditions between uses, these environmental
conditions shall be
-Justified in the risk management file
-Marked on the product, unless not practicable, in which case the more restricted range only needs to be disclosed in the instructions for use.
-Marked on the carrying case, if the instructions for use indicate the product is intended to be transported or stored in a carrying case between uses.
The product shall comply with all of the requirements of the required
standards when operated in NORMAL USE under the following
environmental conditions:
-A temperature range of +5°C to +40°C;
-A relative humidity range of 15% to 93%, non-condensing; and
-An atmospheric pressure range of 700hPa to 1060hPa.
If the instructions for use state a more restricted range of environmental
operating conditions, these conditions shall be:
-Justified in the risk management file
-Marked on the product, unless not practicable, in which case the more restricted range only needs to be disclosed in the instructions for use; and
-Marked on the carrying case, if the instructions for use indicate the product is intended to be operated in a carrying case.
The enclosure of the product shall be marked with the IP classification
required by 8.3.1 of BS EN 60601-1-11:2010. If some or all of the
protection against the ingress of water or particulate matter is provided
by a carrying case, then the degree of protection provided by the
enclosure shall be marked on the enclosure and the degree of protection
provided by the carrying case shall be marked on the carrying case. A
carrying case that is not intended to provide protection against the ingress
of water or particulate matter need not be marked.
If an enclosure does not provide the minimum required degree of
protection against the ingress of water, it shall be marked ‘keep dry’ or
with symbol ISO 7000-0626 (2004-01).
Single use - To be used on products or parts that can only be used
once, i.e. for single use.
For a more detailed list of acceptable symbols, please consult BS EN 980:2008
Please remember that failure to comply with any of the above is a valid reason for rejection of a shipment when HGL or 3rd party Pre Shipment Inspection is undertaken.