For medical device passive components, the part that matters most is the capacitor bridging mains isolation, and Walsin Technology (Walsin)’s X1/Y1 disc capacitors are certified to double or reinforced insulation under IEC 60384-14 for that position. Venatech supplies the part with full lot and date code traceability and a Certificate of Conformity on request. Venatech holds no medical device certification of its own, and claims none.
Venatech Limited, an authorised Walsin distributor in Hong Kong, built this post from Walsin’s disc capacitor and MLCC parametric data — 929 disc capacitor rows and 24,025 MLCC rows — and from the company facts Venatech has confirmed in writing. Every part number below is real. Where a claim is about Venatech itself rather than a Walsin part, it is stated exactly as confirmed, no more.
Can Venatech certify a part for use in a medical device?
No, and this post will not imply otherwise. Venatech is a component distributor, not a notified body, and holds no ISO 13485 or medical device quality system certification. The engineer of record is the one who qualifies a part for a medical device under IEC 60601-1 or whichever standard applies, using the manufacturer’s own certification documents as evidence in the design file.
What Venatech can do is supply the part Walsin certifies, with the paperwork that lets you build that evidence file: the part’s Walsin certification class, full lot and date code traceability, and a Certificate of Conformity on request. That is a sourcing claim, not a certification claim, and the difference matters to a notified body reviewing your file.
What does a “safety-certified” capacitor actually certify?
An insulation class under IEC 60384-14, not a medical-grade rating. X capacitors sit line-to-line, where failure causes no shock hazard. Y capacitors sit line-to-ground, where failure could energise a touchable surface — the position a medical device’s mains isolation barrier typically uses. Y1 is certified for double or reinforced insulation; Y2 for basic or supplementary insulation only.
A medical device’s patient-connected or operator-touchable surface generally needs the higher duty, which is why this post centres on Y1, not Y2. Confirm the exact clause against the current edition of IEC 60384-14 and the specific device standard — this post states the class definitions, not a substitute for that analysis.
Which Walsin safety class matches a reinforced-insulation barrier: X1/Y1 or X1/Y2?
X1/Y1. Walsin’s disc capacitor line carries three X1/Y1 series — AH, AH 500V and AS — and one X1/Y2 series, AC, across several size and voltage variants. Here is one real 1000 pF electrical point across all three X1/Y1-adjacent variants, with the X1/Y2 part alongside it so the class difference is visible at identical capacitance:
| Part number | Series | Capacitance | Tolerance | UR (class and voltage) | Match / mismatch |
|---|---|---|---|---|---|
YP5AH102K090 |
AH, X1/Y1, 500V small size | 1000 pF | ±10% | X1-500Vac/Y1-500Vac 1500Vdc | reference part |
YP0AS102K110 |
AS, X1/Y1 | 1000 pF | ±10% | X1-760Vac/Y1-500Vac | match: capacitance, tolerance, Y1 class, Y-side 500 Vac · mismatch: X1 rated to 760 Vac not 500 Vac, no 1500 Vdc figure published, not the “500V small size” variant |
YP5AC102K080 |
AC, X1/Y2, 500V | 1000 pF | ±10% | X1-500Vac/Y2-500Vac 1500Vdc | match: capacitance, tolerance, X1 voltage, 1500 Vdc figure · mismatch: Y2 class, not Y1 — basic or supplementary insulation only, not the reinforced duty this table is built around |
The X1 and 1500 Vdc numbers on YP5AC102K080 look identical to the Y1 reference at a
glance. The field that actually governs the medical-barrier decision is the Y letter, and
it is easy to miss if the X number is read first. Do not select on the X1 figure — select
on the Y class.
Across the whole disc capacitor extract, 181 of 929 rows (19.5%) are X1/Y1 — the AH and AS series combined — against 186 X1/Y2 rows in the AC series. The AS series carries the highest X1 voltage of any disc part Venatech holds, 760 Vac, but it is still Y1-500Vac on the Y side, the figure that matters for the isolation barrier itself.
For the certification classes themselves, see X1/Y1 vs X1/Y2 safety capacitors. For the AH, AC and AS series laid out series by series, see Disc capacitor safety classes: AH, AC and AS.
Is there a surface-mount safety-certified capacitor, and does it come with more paperwork?
Yes, and it is the better-documented option. Walsin’s S2 series is a safety-certified X1/Y2 MLCC in a surface-mount case, and — unlike every disc part in this post — Venatech holds a datasheet PDF for it, with full L × W × T dimensions published alongside the electrical spec:
| Part number | Dielectric | Capacitance | Tolerance | Rated voltage | L × W × T (mm) |
|---|---|---|---|---|---|
S242B102K502 |
X7R | 1000 pF | ±10% | 5000 Vdc | 4.50 +0.80/−0.30 × 2.00 ±0.25 × 2.00 ±0.20 |
S2 is X1/Y2, not X1/Y1 — basic or supplementary insulation, the same class gap described above applies here too. Specification source: S2 series datasheet — https://www.passivecomponent.com/wp-content/uploads/datasheet/WTC_MLCC_Safety_Certified_S2.pdf. If a design genuinely needs reinforced insulation in a surface-mount footprint, that specific combination is not in Walsin’s S2 catalogue as held by Venatech — ask before assuming it exists.
How much of Walsin’s safety-certified capacitor range do we hold a datasheet for?
173 of 540 — 32.0%. Across Walsin’s disc capacitor and MLCC data, Venatech counts 540 safety-certified capacitor part numbers in total: 367 disc parts across the AH, AC and AS series, plus 173 surface-mount S2 parts. A datasheet PDF exists on file for exactly one of those two groups.
| Family | Class | Parts | Datasheet on file? |
|---|---|---|---|
| Disc — AH, AS | X1/Y1 | 181 | No |
| Disc — AC | X1/Y2 | 186 | No |
| MLCC — S2 | X1/Y2 | 173 | Yes |
| Total | — | 540 | 173 (32.0%) |
The 367 disc parts are also missing body diameter, lead spacing and thickness in Walsin’s own parametric export — every one of those fields is blank across all 929 disc rows, safety-certified or not. For a medical device design file, that means the disc capacitor’s footprint and the datasheet drawing both have to come from Walsin directly; Venatech cannot pull them from an export that does not contain them.
What documentation can Venatech actually provide for a design file?
Three things, stated at the level Venatech can actually back up. First, full lot and date code traceability on parts supplied through Venatech. Second, a Certificate of Conformity available on request for a specific shipment. Third, confirmation that the part was sourced through authorised distribution — direct from Walsin, in original sealed manufacturer packaging, not through a grey-market channel.
What Venatech does not provide: any ISO 9001 or IATF 16949 certification of its own, any medical device quality system certification, and no assertion that a part is “medical grade” beyond the safety class Walsin itself publishes. If your notified body’s checklist asks for Venatech’s own quality certification, the honest answer today is that Venatech holds none, and the qualification evidence for the capacitor itself has to come from Walsin’s own safety certificate for the specific part number and lot.
This is also why this post does not name a customer, a device, or a case study. Venatech holds no published consent to use any customer’s name, and none appears here or anywhere in this corpus.
For the MLCC range generally, see the Walsin MLCC page; the disc capacitor line is on the Walsin disc capacitor page.
The short version
Select on the Y letter, not the X number — Y1 is the reinforced-insulation class a medical device’s isolation barrier typically needs, and Walsin’s AC series parts can show a higher X1 figure than an AH part while only carrying Y2. Of the 540 safety-certified capacitor parts in Walsin’s disc and MLCC data, only the 173 surface-mount S2 parts come with a datasheet Venatech holds; the 367 disc parts do not, and their footprint data has to be requested from Walsin directly. Venatech can hand over traceability and a Certificate of Conformity. Venatech cannot hand over a certification it does not hold, and this post has not claimed one.
Send us the part number or the capacitance, tolerance and class your isolation barrier needs, and we will tell you which Walsin series actually covers it — and what paperwork exists for it today.
Check it against the catalogue yourself. Cross-reference accepts one part number or a whole BOM column and prints the mismatches as plainly as the matches — qualification stays with you, which is the honest division of labour. Ready stock covers the ceramic capacitor lines held in Hong Kong.
Frequently asked questions
Is Venatech ISO 13485 certified for medical device components?
No. Venatech holds no medical device quality system certification and makes no such claim. The qualification evidence for a specific part has to come from Walsin’s own safety certificate, read into your device’s design file by the engineer of record.
What is the difference between an X1/Y1 and an X1/Y2 safety capacitor for a medical design?
Y1 is certified under IEC 60384-14 for double or reinforced insulation; Y2 for basic or supplementary insulation only. A medical device’s mains isolation barrier typically needs the Y1 duty. The X1 rating is a separate, line-to-line figure and does not substitute for the Y class.
Can Venatech provide a Certificate of Conformity for a safety capacitor?
Yes, on request, for parts supplied through Venatech, with full lot and date code traceability. This is a sourcing and traceability document, not a statement that the part is certified for any specific medical device.
Does Walsin publish a datasheet for its disc safety capacitors?
No. Venatech holds no datasheet PDF for the AH, AC or AS disc capacitor series. Every specification in this post for a disc part comes from Walsin’s parametric export. Request the datasheet and the safety certificate from Walsin directly before a design review.
Is there a surface-mount alternative to a leaded disc safety capacitor?
Yes — Walsin’s S2 series, an X1/Y2 safety-certified MLCC in a surface-mount case, for which Venatech does hold a datasheet with full dimensions. It is X1/Y2, not X1/Y1, so the same class consideration applies before specifying it into a reinforced-insulation position.
How many of Walsin’s safety-certified capacitors does Venatech hold a datasheet for?
173 of 540 — 32.0%. All 173 are the surface-mount S2 series. The other 367, all leaded disc parts across the AH, AC and AS series, have no datasheet on file with Venatech.
Does Venatech claim its parts are medical grade?
No. Venatech states the safety class Walsin itself publishes for a part — for example X1/Y1 under IEC 60384-14 — and does not add a “medical grade” label beyond that. The engineer of record qualifies the part against the applicable device standard.
Three ways to get this answered today
1. Cross a part, free. Paste up to 500 part numbers, or drop an Excel or CSV file, into the free cross-reference tool. It is matched against Walsin’s published catalogue and returns candidates field by field, with every difference from your original stated rather than hidden. Filter by commercial or automotive grade, or for soft termination, high temperature, safety certified, high Q / low ESR or low profile. There is no login and no charge.
2. Send the whole BOM. Upload a BOM and request a quote and we will come back line by line — including the lines we cannot help with, which is usually the more useful half of the answer.
3. Check the shelf before you commit. Ready stock shows what was physically in Hong Kong as at 23 September 2026. It is a dated snapshot, never a live feed, and quantities are never permanent.
Why take our word for any of this? Don’t — check it.
Venatech Limited (威納電子有限公司) is an authorised Walsin Technology distributor in Hong Kong. Confirm that with Walsin rather than with us. On the safety capacitor series we hold UL file E182369, which is searchable in UL’s own public database, together with TUV certificates R50381780 and R50195920 and CQC CQC20001280137 and CQC20001280136, against EN 60384-14:2023, IEC 60384-14:2023 and UL 60384-14. We hold 28 Walsin datasheets, 451 pages, and we will send the one covering your part number. Shipments arrive in original sealed Walsin packaging with lot and date-code traceability, and a certificate of conformity is available per shipment on request.
We will also tell you what we do not hold, which no competitor publishes. REACH, SVHC, conflict minerals, PFAS, China RoHS, ISO 9001, IATF 16949, PPAP, IMDS and a Declaration of Conformity appear nowhere in those 451 pages. You would rather hear that from us now than from your own supplier-approval team later. AEC-Q200 is compliant in Walsin’s own words and never certified, we hold no manufacturer’s end-of-life or allocation list for any brand, and qualification in your own circuit stays with you. We will not tell you a part is equivalent. We will show you where it differs.
Venatech Limited · Unit 207, 2/F, Sun Ling Plaza, 30 On Kui Street, Fanling, N.T., Hong Kong · (852) 2628 4777 · Hong Kong, Shenzhen, Singapore and Jiangmen, with Chengdu in preparation.