marking (general such as labeling)

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    CE Marking on Multiple-Components Medical Products

    Hi Experts, I would like to get a better idea on how to CE mark a medical product consisting of multiple components. As an example: a laser focusing hand piece consisting of a hand piece body, different focusing lenses, different sleeves matching in length with the focal length of the lenses...
  2. Q

    Labeling/Marking Location for BF Symbol

    Hi Everyone, Hoping for a bit of guidance on the use of the BF symbol for on product identification. We have a product in development that will require BF marking. During a review yesterday it became apparent that the location requirement for the on product marking may be difficult to...
  3. I

    UDI requirements vs Japanese Barcode Marking guideline

    Hello everyone, According to the Japanese Barcode Marking Guideline, 3 information could be required to be encoded in a MD barcode: its product code (e.g. GTIN), its serial number and its expiration date, if applicable. Looking at US FDA UDI requirements in terms of labeling, the product...
  4. P

    Medical Device Marking - Power Input Ports

    Looking for recommendation on marking a medical device -specifically the input jack to our device--we use a 12V 15Watt external power supply to power our product. 60601 states "Model or Type of the specified power shall be permanently marked on the outside of the equipment..." We use a generic...
  5. F

    Marking Requirements on Drawings (Prints)

    I have often seen generic marking requirements on a drawing (a heat number for example) identified with a dashed box to indicate approximate position. I have run into issues with some vendors who perceive the dashed box as a hidden feature and interpret it to be on the reverse. Is there some...
  6. C

    CE Mark Label Symbol Requirements on a Medical Device

    Hello, My company is pursuing a CE mark on a medical device, and a question has come up regarding how flexible the label and symbol design is while still complying with ISO/CE standards. Are the symbols specified in documents like 60601-1-8 or 60601-1 exactly what should be used in the...
  7. I

    Faster way to Tag Parts for Painting

    We are AS9100 FAA TC EASA Maintenance and Manufacturing facility. We fabricate parts in house. I was asked to search for something by our Paint department. We require tags for parts for before and after painting. Something that won't be obscured by the paint process. We have parts that get metal...
  8. M

    Compliance Marks on Labeling - Required, recommended, or useless?

    Hi Everyone, With regards to labelling an electrical medical device in the EU: Obviously, the CE mark is required. But what about the following: - WEEE mark - RoHS mark - GS mark (for Germany?) - Mark to show EN60601-1 compliance (such as the TUV T-mark) Are the above marks: - Required to be...
  9. C

    Standard for Marking Traceability ID Characters onto a Part

    We have thousands of part prints, and most of our parts require traceability. We do this by stamping, etching, etc. the Trace ID into each component. My problem is that there is no consistency as to how to show the required marking on the part print. Some prints want the lettering to be .060"...
  10. K

    Marking Aerospace parts after concession/deviation & use as is dispositioning

    Our current MRB procedure includes identification of machined parts after a use-as-is disposition. However, sometimes not all pieces in a lot are non-conforming (or have different non-conformances). We operate under FAR Part 21 and will soon be AS9100. My question: If some parts are...
  11. C

    Marking of Polymeric Parts - How does it look like?

    Hello all! I'm looking for a general understanding of how marking of polymeric parts (clause of PPAP manual) looks like. Maybe someone can post a photo of a part? I wasn't able to google it... :confused:
  12. S

    Marking of Tensile Test Specimen

    So...I am looking for something to mark our tensile test specimen. I've searched and I am unable to find a satisfactory device. The one that was the closest is Tensilmark from Tensilkut, The description (from their website): "The Tensilmark is a compact, freestanding unit designed to scribe...
  13. sridharafep

    Logo Marking for Marketing purpose - ISO 9001, ISO 14001 and OHSAS 18001

    As per the standard ISO 17021 ISO log shall not be used on the product or product packaging seen by the consumer as mentioned in ISO 17021 clause 8.4.1 “A certification body shall have a policy governing any mark that it authorizes certified clients to use. This shall assure, among other...
  14. C

    FAA/PMA Part Marking Requirements

    I work for an injection molding facility that manufactures parts for Boeing. Occasionally, we are asked by aftermarket suppliers for some of the parts we are on contract to make for Boeing. Our contract states that we are not authorized to sell parts off the Boeing owned tools to a third...
  15. P

    Marking Legibility (7.1.2 of IEC 60601-1): Size of Letters

    As a test engineer I've already come across a couple of cases with very small letters. According to IEC 60601-1, marking should be visible at 1m by a person with 20/20 vision, in light varying from 100-1500 lx. Many people already know this test is very subjective, so I did some research to...
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